Bluegrass Vascular Technologies recently announced positive results from a clinical study of its Surfacer Inside-Out catheter system.

The San Antonio-based company said the trial represents the first independent, multicenter study investigating the applicability of the Surfacer system, which is designed to provide access to the jugular vein to restore central venous access in hemodialysis patients with blocked neck veins. The trial’s results were published in the American Journal of Kidney Diseases.

The Surfacer is designed to be threaded through the femoral vein up to and into blockages in the jugular, which acts as a stabilizer. The head of the catheter is then aligned via fluoroscopy with a target on the surface of the neck, and a needle guide is advanced through to the skin. A sheath is then inserted, the Surfacer retracted and a central venous catheter is attached to the sheath, according to the company.

The study enrolled 32 patients, of whom 83% had either Type 3 or 4 complex obstructions (three or more occluded vessels). Of those enrolled, 97% met both the primary and secondary efficacy endpoints of achieving central venous access through the use of the Surfacer system and catheter patency at three months, the company reported. No procedure-related complications were observed and no catheter-related infections occurred within the first week after catheter placement.

“Thoracic central venous occlusion is a significant issue, which can impact long-term morbidity, particularly in hemodialysis patients who depend on central venous catheters for dialysis therapy,” said Dr. Roman Reindl-Schwaighofer of the Division of Nephrology at Medical University Vienna, and first author on the study. “This study demonstrates that the Surfacer system is a reliable and safe means of repeatedly establishing vascular access, currently a challenge with alternative surgical options or sharp recanalization techniques.”

“The erosion of subclavian and left-sided vascular access routes are of great concern to this patient population due to their higher rates of central stenosis and catheter dysfunction,” added Dr. Vladimir Matoussevitch, M.D., vascular surgeon and head of the vascular access unit at the University Hospital of Cologne in Germany.

The Surfacer device won CE Mark approval in the European Union in August 2016; Bluegrass later inked an EU distribution deal with Merit Medical (NSDQ:MMSI) that included an equity stake.

“This study adds to the growing body of evidence highlighting the need for standardized treatment of central venous occlusions and demonstrating the positive clinical impact of the Surfacer System,” said Bluegrass Vascular president & CEO Gabriele Niederauer. “We look forward to broadening our clinical partnerships in Europe and the U.S. to best support this effort.”

Source: Source: https://www.medicaldesignandoutsourcing.com/bluegrass-vascular-touts-results-of-surfacer-catheter-trial/

December 27th 2019

SAN ANTONIO, Dec. 19, 2019 /PRNewswire/ -- Bluegrass Vascular Technologies (Bluegrass Vascular), a private medical technology company focused on innovating lifesaving devices and methods for vascular access procedures, announced today the publication of positive results associated with a clinical study involving the use of the Surfacer® Inside-Out® Access Catheter System in the peer-reviewed American Journal of Kidney Diseases.

The publication highlights the first-ever independent, multicenter study investigating the applicability of the Surfacer System, a novel approach to achieving right-sided, upper body central venous access in patients with obstructions or other conditions that preclude central venous access by conventional methods. The study was directed by lead investigator and the publication's senior author, Gürkan Sengölge, M.D., Associate Professor of Medicine, Nephrology and Intensive Care Medicine at the Medical University of Vienna. Dr. Sengölge is a long-time supporter of the Surfacer System, approaching 50 cases successfully completed to-date.

The present study enrolled 32 patients, the majority (83%) of which had either Type 3 or 4 complex obstructions (3 or more occluded vessels). Of those enrolled, 97% met both the primary and secondary efficacy endpoints of achieving central venous access through the use of the Surfacer System and catheter patency at 3 months. No procedure-related complications were observed and no catheter-related infections occurred within the first week after catheter placement.

"Thoracic central venous occlusion is a significant issue, which can impact long-term morbidity, particularly in hemodialysis patients who depend on central venous catheters for dialysis therapy," explained Roman Reindl-Schwaighofer, M.D., from the Division of Nephrology at Medical University Vienna, and first author on the study. "This study demonstrates that the Surfacer System is a reliable and safe means of repeatedly establishing vascular access, currently a challenge with alternative surgical options or sharp recanalization techniques."

"The erosion of subclavian and left-sided vascular access routes are of great concern to this patient population due to their higher rates of central stenosis and catheter dysfunction," stated Vladimir Matoussevitch, M.D., Vascular Surgeon and Head of the Vascular Access Unit at the University Hospital of Cologne in Germany.

Mr. James Gilbert, Transplant and Access Surgeon from University Oxford Hospitals NHS Trust, further emphasized the clinical importance of the system, pointing out: "the Surfacer System supports the recommended 'always right, never subclavian' approach to preserving vascular real estate in a challenging patient population."

"This study adds to the growing body of evidence highlighting the need for standardized treatment of central venous occlusions and demonstrating the positive clinical impact of the Surfacer System," stated Gabriele Niederauer, Ph.D., CEO and President of Bluegrass Vascular. "We look forward to broadening our clinical partnerships in Europe and the U.S. to best support this effort."

About Bluegrass Vascular Technologies
Bluegrass Vascular Technologies is a medical technology company dedicated to developing and commercializing lifesaving devices and methods that address shortcomings in vascular access procedures. For more information, please visit www.bluegrassvascular.com.

Source: https://www.prnewswire.com/news-releases/american-journal-of-kidney-diseases-publishes-positive-clinical-results-in-first-independent-multicenter-study-of-the-surfacer-inside-out-access-catheter-system-300978039.html

December 19th 2019

- DNX-2401 and Pembrolizumab Combination Shows Clinical Benefit in Recurrent Glioblastoma
- Data Show Interim Median Overall Survival of 12.3 Months

HOUSTON, Nov. 24, 2019 /PRNewswire/ -- DNAtrix, a leader in the development of oncolytic viruses for cancer therapy, today presented updated safety and efficacy data from the fully-enrolled Phase 2 CAPTIVE / KEYNOTE-192 study of DNX-2401 (tasadenoturev), DNAtrix's oncolytic adenovirus, followed by pembrolizumab for patients with recurrent glioblastoma. The data demonstrate that the therapy elicits durable clinical activity and has a favorable safety profile. These results are being presented at the Society for Neuro-Oncology (SNO) Annual Meeting held from November 22-24, 2019 in Phoenix, Arizona.

A total of 48 patients with recurrent glioblastoma were treated at 15 participating clinical sites with the regimen of DNX-2401, followed by pembrolizumab. The majority of patients experienced clinical benefit following treatment, including durable complete and partial responses. Interim median overall survival for patients is currently 12.3 months. In addition, the interim safety analysis demonstrates that the therapy has a positive benefit-risk profile, there were no unanticipated adverse events and patients remained on pembrolizumab for a median of 5.5 months with a maximum of 34 cycles.

"The data hold great promise for patients afflicted with glioblastoma, the most common form of adult brain cancer. Glioblastoma is a disease associated with near uniform fatality. The results are striking in this context," said Clark Chen, MD, PhD, Professor, Lyle French Chair in Neurosurgery and Department Head at the University of Minnesota, presenting author for the CAPTIVE / KEYNOTE-192 study. "The results suggest that the combination of DNX-2401 and pembrolizumab has the potential to revolutionize the care of glioblastoma patients. I look forward to the rigorous studies aimed to validate the efficacy of DNX-2401."

"These interim data from our CAPTIVE trial are a significant milestone for us in the development of DNX-2401 as an innovative treatment for glioblastoma," said Frank Tufaro, PhD, CEO of DNAtrix. "Importantly, these data suggest that DNX-2401 has a superior clinical benefit and safety profile compared to currently approved chemotherapy for recurrent glioblastoma, and we are particularly pleased that, together with pembrolizumab, DNX-2401 elicited a number of robust and durable antitumor responses."

About CAPTIVE / KEYNOTE-192
CAPTIVE / KEYNOTE-192 is a Phase 2 multicenter study evaluating a single intratumoral injection of DNX-2401 (tasadenoturev) followed by standard dosing with pembrolizumab every three weeks to determine the safety and efficacy in patients with recurrent glioblastoma.

About DNX-2401 (Tasadenoturev)
DNX-2401 is an oncolytic adenovirus engineered specifically to infect, replicate in, and kill cancer cells to elicit an immune response. Prior clinical studies have demonstrated that DNX-2401 was well tolerated and extended survival for patients with recurrent glioblastoma. DNX-2401 is currently being evaluated in several clinical trials, including a multicenter Phase 2 study evaluating DNX-2401 with pembrolizumab for adult patients with recurrent glioblastoma. DNX-2401 has been granted PRIME and Orphan designation by the EMA, and Fast Track and Orphan designation by the FDA.

About DNAtrix
DNAtrix is a privately held, clinical stage, biopharmaceutical company developing oncolytic virus immunotherapies for cancer. Its oncolytic adenovirus platform is based on genetic modifications to the common cold virus that allows for the virus to specifically infect and kill cancer cells while leaving healthy cells unharmed. The company's investors include Morningside Ventures and Mercury Fund. For more information, please visit the company website at www.DNAtrix.com.

Contact
DNAtrix Inc.
Karen Basbaum
SVP Business Development
kbasbaum@dnatrix.com

Stern Investor Relations
Daniella Funaro
Daniella.Funaro@sternir.com
212-362-1200

Source: https://www.prnewswire.com/news-releases/dnatrix-presents-positive-results-from-the-phase-2-captivekeynote-192-study-of-dnx-2401-in-combination-with-pembrolizumab-for-glioblastoma-at-the-2019-sno-annual-meeting-300964206.html

November 24th 2019

EDMONTON, Canada--(BUSINESS WIRE)-- iTraumaCare®, an early-stage medical device company focused on developing traumatic injury solutions for first responder, emergency medicine and military medicine applications, announced today that its iTClamp® Hemorrhage Control System has been recommended by the U.S. Department of Defense’s Committee on Tactical Combat Casualty Care (CoTCCC).

CoTCCC recommends the use of the iTClamp as a primary option for external hemorrhage of the head and neck, and as an alternative adjunct for massive compressible external hemorrhage not amenable to limb tourniquet use or as an adjunct to tourniquet removal.

“CoTCCC’s decision to include the iTClamp in its recommendations is driven by the need for a hemorrhage control tool that addresses life threatening bleeding from the head and neck region. This is a strong validation of the quality and effectiveness of our device,” commented Joe Brennan, CEO of Innovative Trauma Care. “Multiple independent and peer-reviewed studies have shown that the iTClamp is an excellent choice for controlling hemorrhage in both military and civilian applications, and we look forward to greatly expanding use of the iTClamp across a wide variety of scenarios.”

The iTClamp Hemorrhage Control System has FDA 510(k) clearance and is designed to control bleeding in seconds in the scalp, neck, extremities, groin and axilla areas. The iTClamp seals the edges of a wound closed to create a temporary hematoma under pressure that mitigates further blood loss until the wound can be surgically repaired.

Incorporated in 2010 and based in Edmonton, Canada, iTraumaCare is addressing unmet needs in the fields of emergency and military medicine by developing, manufacturing, and commercializing solutions to treat common causes of preventable death in traumatic injury scenarios.

Source: https://www.businesswire.com/news/home/20190910005083/en/

September 11th 2019

Xconomy Texas — San Antonio — Ah, to be able to regrow a missing limb like a slimy salamander—a trick long dreamed of by youngsters and scientists alike.

Research into such regenerative abilities has increasingly excited the scientific community during the past 30 years as it has gained further insight into the potential of the extracellular matrix, a part of all biological tissue that acts like the scaffolding for cells. In particular, researchers are interested in the potential that extracellular matrices (ECM) may have in signaling and regulating stem cells, something that someday could be used to repair and regenerate human tissues. Science is nowhere near anything like limb regrowth, but numerous advances have been made since the first discoveries, made in the 1980s, revealed the potential applications of extracellular matrices.

“As we learn more about organ-specific matrix composition and functionality, we may be able to rationally modify matrices to drive desired regenerative outcomes in vitro and in vivo,” wrote Laura Niklason, a professor of anesthesiology and biomedical engineering at Yale University, in the scientific journal Cell Stem Cell in 2018. “Eventually, we may even generate completely synthetic matrices that can act as agents for directing tissue restoration in humans.”

One of the pioneers of ECM research, Stephen Badylak, is slated to receive an award in September from San Antonio biomedical advocacy group BioMed SA for his work, which includes founding two companies, gaining more than 70 patents, and publishing hundreds of scientific articles on the topic. Badylak is the deputy director of the McGowan Institute for Regenerative Medicine at the University of Pittsburgh, which announced July 12 he is slated to receive the award. In addition to his academic work, Badylak is involved with several startups developing ECM-related products.

He is the co-founder of Pittsburgh-based ECM Therapeutics, which makes diagnostic and therapeutic products from ECMs, including a hydrogel the company believes can mobilize and differentiate stem cells to stimulate healing. It has raised about $2.4 million of $5 million in planned funding as of June, according to a securities filing.

StemBioSys, a San Antonio-based company founded in 2010 that makes an extracellular matrix technology used for replicating stem cells, has collaborated with Badylak for two years on new applications of the company’s ECMs, which are derived from a type of stem cell in human bone marrow. What Badylak discovered surprised StemBioSys: The company’s matrices had small packets of RNA, the molecular messengers that carry the genetic instructions for proteins, which could direct cell behavior, according to Chief Operating Officer Sy Griffey.

StemBioSys was excited by the discovery, Griffey writes in an email, because it may mean that the company can expand its technology, and because the packets, or vesicles, of RNA that Badylak discovered appear to be distinct from other RNA-carrying biological bubbles, known as exosomes. Exosomes, once thought to be cellular garbage bins, now are popular in scientific research. They first spurred diagnostic companies, such as Cambridge, MA-based Exosome Diagnostics, which Bio-Techne bought for $250 million last year. Now, Codiak Biosciences, another Cambridge startup that cancelled its plans for an IPO this month, is seeking to make therapeutics using exosomes as delivery devices.

For StemBioSys, working with Badylak has meant developing customized forms of its matrix, which Badylak uses to make comparisons depending on the cell type used to make the matrix, says StemBioSys CEO Bob Hutchens. The lab work is being done at the University of Pittsburgh and the two organizations have an agreement in place that deals with ownership, Hutchens says in an interview.

“It’s very exciting work, and these matrix-bound vesicles in the long term could have some really interesting applications, including in therapy,” he says.

Badylak also previously served on the scientific advisory board for BioBridge Global, a San Antonio life sciences nonprofit that operates multiple subsidiaries focused on regenerative medicine, according to a spokesperson for BioMed SA, which said Wednesday it had selected Badylak as the recipient of its annual award for innovation in healthcare and science. Previous winners include vaccine researcher and Army surgeon George Peoples and prolific biotech founder Robert Langer.

Badylak’s history with ECMs dates to the late 1980s, when he was working at Purdue University and began exploring surgically removing the aorta of dogs, replacing it with a piece of the dog’s small intestine, according to a profile in Discovery Magazine from 2011. (One surgical resident who worked with Badylak “called the operation ‘cruel’ and ‘ridiculous’ and refused to participate,” the article says.) The results Badylak reported appeared astounding: The animals responded well and, in one dog that he operated on again to examine the results of the surgery, he discovered that the aorta had regrown. Badylak published findings in 1989.

Applications of the process have been used to varying degrees over the past 30 years, including in attempting to aid people dealing with horrific accidents and for injuries sustained by military members, such as wounded soldiers treated as part of various Department of Defense-funded studies at the University of Pittsburgh. The patients, who had severe muscle injuries and received ECM implants derived from pig tissue, showed improvement in strength and range of motion, according to research publications and news reports. The procedure has been used on soldiers in San Antonio, where there is a large military presence, by organizations such as the US Army Institute of Surgical Research.

“I am honored to receive this recognition, especially coming from BioMed SA and San Antonio where much of our early research into ECM was successfully applied to help wounded warriors,” Badylak said in a news release.

Source: https://xconomy.com/texas/2019/07/17/san-antonio-to-honor-regenerative-medicine-pioneer-stephen-badylak/

July 17th 2019

BioMed SA has selected Dr. Stephen Badylak, professor of surgery and bioengineering at the University of Pittsburgh and deputy director of the McGowan Institute for Regenerative Medicine, to receive its 2019 Award for Innovation in Healthcare and Bioscience.

Badylak discovered the use of the extracellular matrix, or ECM, which has been shown to ignite cell regeneration and regrowth of damaged tissue. More than 10 million patients have benefited from his discoveries, including wounded warriors, through his collaboration with the U.S. Army Institute of Surgical Research and other San Antonio-based organizations focused on advancing regenerative techniques for military and civilian use.

“Regenerative medicine is a burgeoning industry globally, and San Antonio’s unique assets make this emerging field of medicine a key opportunity for growth here in our sector,” BioMed SA President Ann Stevens said. “Dr. Badylak’s discoveries have unlocked huge potential opportunities for the future of cell regeneration both here and worldwide.”

Badylak, who will accept the award at BioMed SA’s annual award dinner in San Antonio on Sept. 19, has additional ties to the Alamo City. He is working with San Antonio-based biotech StemBioSys Inc. as a research collaborator, helping to further characterize active components in the company’s commercially available stem cell matrix product.

StemBioSys Chief Operating Officer Sy Griffey said collaboration with Badylak could lead to several opportunities to expand the company’s technology.

“Dr. Badylak’s discoveries have had a significant influence on what we are doing in San Antonio and for the future of patient care,” StemBioSys CEO Bob Hutchens said.

Hutchens — who chaired the 2019 award selection committee for BioMed SA, a nonprofit corporation founded in 2005 to promote and grow San Antonio’s health care and bioscience industry — said Badylak’s contributions have grown the industry and “enhanced the quality of life for patients with traumatic injuries worldwide and have blown the lid off of the potential for tissue regeneration in the future.”

Badylak has more than 70 U.S. patents and more than 300 patents worldwide. More than 40 of those have been licensed to industry. He has also founded two biotech companies and is a member of the College of Scientific Reviewers for the National Institutes of Health.

“I am honored to receive this recognition, especially coming from BioMed SA and San Antonio, where much of our early research into ECM was successfully applied to help wounded warriors,” Badylak said.

Source: https://www.bizjournals.com/sanantonio/news/2019/07/17/biomed-sa-to-honor-regenerative-medicine-pioneer.html

July 17th 2019

AXT is pleased to announce it has further enhanced its cellular research product portfolio through the addition of stem cell solutions from StemBioSys. The recently signed agreement will see AXT distribute StemBioSys’ unique solutions to researchers in Australia and New Zealand.

StemBioSys is a US-based company that specializes in producing human-derived stem cell products.

With a range of human cell-lines and derived matrix, StemBioSys products are used to more accurately mimic the in vivo physiological conditions during in vitro cell culture.

StemBioSys currently carries two broad product ranges CELLvo™ Matrix and CELLvo™cells.

CELLvo™ Matrix is the only commercially available substrate that aims to recapitulate biochemical as well as structural and mechanical cues of the native niche by leaving the extracellular matrix intact.

Completely Cell-derived this matrix creates a biologically-relevant culture environment in vitro for a variety of cell types by providing all the cues cells expect to receive in vivo. For researchers, this means that the response of cells to experimental variables can be directly assessed eliminating complicating effects induced by standard in vitro culture conditions.

CELLvo™ cells maintain a far more natural phenotype compared to standard derived cells and are cultured and isolated using the physiologically relevant Cellvo Matrix technology. A range of cell types are currently offered. These are early-passage and have xeno-free versions where possible. All cells are sourced from young, healthy tissue and have never seen plastic ensuring customers top quality cells. StemBioSys® are committed to continual improvement and are continuing to bring new cell products to the market.

StemBioSys President & CEO Bob Hutchens said:

“Australia and New Zealand are leading areas in cell research, and we are delighted to have the opportunity to gain meaningful access to this market though our partnership with AXT. AXT is a recognized life science tool company with deep technical expertise. AXT carries a full range of complementary products and we are very excited to announce them as our new distributor in these markets. We believe that this will be a great partnership for AXT, StemBioSys and for researchers in Australia and New Zealand."

Richard Trett, Managing Director of AXT, said:

“Australia is a leading light in medical research. Stem Cell research is a key area of development that holds great potential for many areas such as genetics and drug development. We are excited to be able to extend our range of tools that can assist with their ground-breaking work."

StemBioSys CELLvo Matrix and CELLvo Cells will complement other AXT cell-related products lines such the Nanolive 3D Cell Explorer holotomographic microscope, sample management solutions from TTPLabtech and organ-on-a-chip systems from CN Bio Innovations.

Source: https://www.news-medical.net/news/20190625/AXT-enhances-cellular-research-product-portfolio-with-solutions-from-StemBioSys.aspx

June 25th 2019

Having commercial success with its initial medical device in Europe, Bluegrass Vascular Technologies Inc. has had a far tougher time clearing the regulatory hurdles impeding its entry to the U.S. market.

San Antonio-based Bluegrass Vascular — seeking the U.S. Food and Drug Administration's approval to market its Surfacer System device, intended to facilitate greater central venous access — has had to adjust to the FDA's changing stance on what kind of product the company has.

Initially, the FDA deemed the Surfacer System a class II, or medium risk, device, which Bluegrass Vascular CEO Gabriele Niederauer said typically requires a company to demonstrate to the regulatory agency that its device is safe, effective and substantially equivalent to a “legally marketed device.” However, after Bluegrass Vascular filed its appropriate application, the FDA changed its determination, saying the Surfacer System was not substantially equivalent to an approved device. So the company has had to switch gears and pursue U.S. commercialization through a de novo classification for novel devices.

“We essentially have to provide assurance [in the U.S.] of safety and effectiveness," Niederauer said, despite the fact that Bluegrass Vascular's product has been working safely for European patients. She said the company has compiled more than 200 reported cases substantiating its device's success in Europe.

“We’ve been on the market in Europe for almost three years, and we are getting great results there,” she said. “In the U.S., it’s taking much longer.”

The company — which launched in 2011 and moved here in 2014 from Lexington, Kentucky — is not alone. Critics say roadblocks to commercialization in this country are stifling medical advancements and unnecessarily putting more people at risk as bioscience companies wait to get novel technologies to patients and providers.

Meanwhile, once the FDA approves the de novo classification for Bluegrass Vascular, it will smooth a regulatory path for others who follow.

FDA officials wouldn’t say much about Bluegrass Vascular's situation, noting that the agency is limited in what it can share regarding companies and products awaiting approval.

The good news for Bluegrass Vascular is that it has been frugal with its resources during its long march to market. The company secured $5 million from Merit Medical Systems Inc. [Nasdaq: MMSI], which confirmed in December 2016 its investment in a Series B fundraising. For now, Niederauer said there is no need for another funding round.

“We have probably spent half of what other companies spend to get their product to where we are,” she said.

At the same time, other potential funders are noticing Bluegrass Vascular’s success outside the U.S.

“We have investors who continue to be very interested in us,” Niederauer said.

Source: https://www.bizjournals.com/sanantonio/news/2019/06/19/sa-biotech-encounters-more-regulatory-hurdles-to-u.html

June 19th 2019

Emergency room staff nurse Victoria LoConte reveals her interest in past findings surrounding pulsed xenon ultraviolet light disinfection in hospital settings.

LYNN, MASSACHUSETTS, USA, June 18, 2019 /EINPresswire.com/ -- A study previously conducted at Cambridge Health Alliance's Everett Hospital demonstrated that pulsed xenon ultraviolet light disinfection was capable of significantly reducing operating room contamination of both surfaces and air. Today an emergency room staff nurse at the same facility, Victoria LoConte looks back on the study's findings and her own research paper delving into the implementation of such systems as part of her training.

CHA Everett Hospital is a 162-bed hospital in Everett, Massachusetts, and one of three hospitals which together form Cambridge Health Alliance, a Harvard Medical School teaching affiliate. The study, presented during an Association for Professionals in Infection Control and Epidemiology annual meeting, demonstrated that Xenex Healthcare Services' disinfection system reduced surface contamination by 81 percent, and air contamination by 46 percent. "The study also showed that between-case contamination continued to rise with standard cleaning, but was reduced to almost zero when the device was used," reveals Victoria LoConte.

"I found the 2013 study to be extremely interesting," explains the emergency room staff nurse, "and completed a research paper on the implementation of Xenex disinfection systems in emergency room settings as part of my own studies."

According to the product's makers, each year in the United States, approximately the same number of people lose their lives as a result of healthcare-associated infections as do from breast cancer, AIDS, and auto accidents combined. "As antimicrobial resistance increases, such infections will likely become even more life-threatening and costly to address," suggests LoConte, "which is why advances in disinfection system technology are so important."

As the market leader in environmental disinfection, Xenex Healthcare Services has today helped more than 400 hospitals in America to achieve healthcare-associated infection rate reductions, according to the company.

LoConte's paper, a change proposal titled 'Xenex Utilization in the ER,' determined that considerable substantiating evidence was present to indicate the effectiveness of the Xenex device in preventing the spread of infection by eliminating contagions. "Utilization in the emergency room was identified as a challenge, however, due to knowledge deficits and patient flow," she adds.

Her proposal, she says, was aimed at improving these issues and ultimately reducing, in particular, rates of Clostridium difficile infection.

Victoria's work covered organization, improvement opportunity, purpose, proposal initiative, leadership, proposal care support, value-based support, data evidence, strategies, strategy defense, change theory, change assessment, quality outcomes, communication, data flow, and more.

"In essence, I found," she adds, wrapping up, "that while strong leadership was required at all steps to ensure success, sustainability, and quality assurance, the Xenex device was, in fact, proven highly effective in preventing the spread of infection via the successful elimination of contagions."

Victoria LoConte is an emergency room staff nurse at CHA Everett Hospital in Everett, Massachusetts. She holds an associate's degree in nursing, obtained from the Lawrence Memorial School of Nursing with Regis College and a bachelor's degree in nursing from Southern New Hampshire University. Prior to her current position, LoConte has also worked as an urgent care facility nurse manager, a case manager, and as a skilled visiting nurse serving the Greater Boston area. Her experience includes adult, geriatric, and pediatric care.

Source: https://www.einnews.com/pr_news/488361771/victoria-loconte-looks-back-on-everett-hospital-xenex-system-study

June 18th 2019

The SAVE-US (Surfacer system to facilitate access in venous occlusions—United States) pivotal trial has completed enrollment. The SAVE-US trial is evaluating the safety and efficacy of the Surfacer Inside-Out access catheter system (Bluegrass Vascular Technologies) in 30 patients across seven US centres, and demonstrated positive clinical results by meeting its primary and secondary endpoints.

According to a press release, the Surfacer system is a novel approach to achieving right-sided, upper body central venous access in patients with upper body venous occlusions or other conditions that preclude central venous access by conventional methods.

“I am quite encouraged by the highly positive results demonstrated by the Surfacer system,” states Mahmood Razavi, an interventional radiologist at St Joseph Hospital in Orange, USA, and lead investigator of the SAVE-US study. “I am eager for the system’s commercial approval, and look forward to offering a reliable and repeatable solution to patients with varying occlusion types, halting the devastating impact of central venous occlusive disease.”

Of the thirty patients enrolled in the US IDE SAVE-US trial, 90% met both the primary and secondary efficacy endpoints of facilitated central venous access by the Surfacer system. On average, central venous access was achieved in approximately 12 minutes despite a more complex patient population comprised largely of Type 3 and 4 occlusions (three or more occluded vessels).

“The Surfacer system passed the SAVE-US study with flying colours, confirming the system is a safe, viable option for achieving right-sided central venous access, preserving secondary central veins,” comments Ehab Sorial (Division of Vascular Surgery, Stanford, USA; Santa Clara Valley Medical Center, San Jose, USA), the study’s second highest enroller. Sorial first learned about the Surfacer system while working alongside John Gurley, the system’s inventor, for over a decade at the University of Kentucky, Lexington, USA. “This is a highly anticipated treatment that gives physicians a safe and effective alternative to other less efficacious treatments with higher complication rates. I am looking forward to its commercial approval and implementing it into my day-to-day practice.”

Bluegrass Vascular Technologies anticipate that the Surfacer system will be commercial available to physicians in 2020.

Source: https://vascularnews.com/save-us-pivotal-trial/

June 4th 2019

SAN ANTONIO, June 4, 2019 /PRNewswire/ -- Bluegrass Vascular Technologies (Bluegrass Vascular), a private medical technology company focused on innovating lifesaving devices and methods for vascular access procedures, announced today it has successfully completed enrollment of the SAVE-US (Surfacer® System to Facilitate Access in VEnous Occlusions – United States) pivotal trial evaluating the safety and efficacy of the Surfacer® Inside-Out® Access Catheter System in thirty patients across 7 U.S. centers. The trial demonstrated positive clinical results by meeting its primary and secondary endpoints.

The Surfacer System is a novel approach to achieving right-sided, upper body central venous access in patients with upper body venous occlusions or other conditions that preclude central venous access by conventional methods.

"I'm quite encouraged by the highly positive results demonstrated by the Surfacer System," stated Mahmood Razavi, MD, Interventional Radiologist at St. Joseph Hospital in Orange, California and lead principal investigator of the SAVE-US study. "I am eager for the system's commercial approval and look forward to offering a reliable and repeatable solution to patients with varying occlusion types, halting the devastating impact of central venous occlusive disease."

Of the thirty patients enrolled in the US IDE SAVE-US trial, 90% met both the primary and secondary efficacy endpoints of facilitated central venous access by the Surfacer System. On average, central venous access was achieved in approximately 12 minutes despite a more complex patient population comprised largely of Type 3 and 4 occlusions (3 or more occluded vessels).

"The Surfacer System passed the SAVE-US study with flying colors, confirming the system is a safe, viable option for achieving right-sided central venous access, preserving secondary central veins," stated Ehab Sorial, MD, Clinical Associate Professor of Surgery in the Division of Vascular Surgery at Stanford in California, staff surgeon at Santa Clara Valley Medical Center in San Jose, CA and the study's second highest enroller. Dr. Sorial first learned about the Surfacer System while working alongside John Gurley, MD, the system's inventor, for over a decade at the University of Kentucky. "This is a highly anticipated treatment that gives physicians a safe and effective alternative to other less efficacious treatments with higher complication rates. I am looking forward to its commercial approval and implementing it into my day-to-day practice."

"I am grateful to the excellent team of physicians who contributed to the SAVE-US study's outstanding success," stated Gabriele Niederauer, Ph.D., CEO and President of Bluegrass Vascular. "I am eager to achieve the next major milestone of U.S. regulatory approval and anticipate that this hugely valuable treatment will be available to physicians and their patients in 2020."

The Surfacer System clinical program includes evidence from 216 cases in subjects with central venous occlusions including results from the US IDE SAVE-US trial, international SAVE registry, independent studies and commercial use surveys.

About the Surfacer® Inside-Out® Access Catheter System

The Surfacer System is designed to reliably, efficiently and repeatedly gain central venous access by inserting the Surfacer System through the femoral vein and navigating it up through the patient's venous system with an exit point in the right internal jugular vein, the optimal location for placing a central venous catheter. This proprietary Inside-Out approach allows for the placement and maturation of permanent arteriovenous access options that are associated with improved patient outcomes and reduced cost of care for both hospitals and hemodialysis providers. The Surfacer System is CE marked and distributed in Europe by Merit Medical, a prominent global distributor of medical devices.

About Bluegrass Vascular Technologies

Bluegrass Vascular Technologies is a medical technology company dedicated to developing and commercializing lifesaving devices and methods that address shortcomings in vascular access procedures. For more information, please visit www.bluegrassvascular.com

Source: https://finance.yahoo.com/news/bluegrass-vascular-announces-enrollment-completion-110000368.html

June 4th 2019

Aerin Medical, Inc., an Austin, Texas-based medical technology company, closed on a $50m non-dilutive term loan agreement with CRG LP.

Aerin received $35m at closing and will receive an additional $15m in two tranches upon achieving certain milestones.

The company used approximately $16.5 million of these proceeds to retire its existing debt. The remaining proceeds will be used to accelerate its sales and marketing reach and to launch its next product.

Led by Fred Dinger, Chief Executive Officer, Aerin Medical focuses on improving the quality of life for patients suffering with nasal airway disorders through the development and commercialization of disruptive minimally-invasive treatments.

The company manufactures and markets the Vivaer® Nasal Airway Remodeling System for the treatment of nasal obstruction. The Vivaer® treatment is a minimally invasive procedure, performed in a physician’s office.

Source: http://www.finsmes.com/2019/05/aerin-medical-receives-50m-debt-facility.html

May 22nd 2019

Positive results of single-center, prospective study to be presented along with several educational sessions

SAN ANTONIO - Bluegrass Vascular Technologies (Bluegrass Vascular), a private medical technology company focused on innovating lifesaving devices and methods for vascular access procedures, announced today events taking place at the Charing Cross (CX) International Symposium this week in London, United Kingdom on April 15-18, 2019. Leading clinicians will discuss experience with the Surfacer® Inside-Out® Access Catheter System. The Surfacer System is indicated for obtaining central venous access to facilitate catheter insertion in patients with diminished upper body access.

Positive results from a single-center, prospective observational study of the Surfacer System demonstrating a 100% success rate in all patients will be presented on April 16th from 2:42 - 2:47 pm BST by Tobias Steinke, M.D., Chief of Vascular and Endovascular Surgery, Schön Klinik, Düsseldorf, Germany. The session titled "The Surfacer System - a single-center prospective observation study in central venous occlusion to demonstrate safety and efficacy" adds to the growing body of strong clinical evidence supporting the Surfacer System during routine commercial use.

"I look forward to sharing the compelling clinical results assessing the safety and efficacy of the Surfacer System as a viable treatment for central venous obstructions," stated Dr. Steinke, an investigator of the SAVE Post-Market Registry and presenter of the study's results at the 2019 Leipzig Interventional Course (LINC). "The Surfacer System continues to be an important tool used to reliably gain access and guard against the damaging and often deadly progression of this disease frequently experienced by patients in my clinical practice."

"The Surfacer System is an innovative approach to a long-standing problem that achieves sustainable access and delivery of life-saving treatments to patients, such as those requiring hemodialysis," stated James Gilbert, M.D., Consultant Transplant & Vascular Access Surgeon at Oxford University Hospitals NHS Foundation Trust. "I look forward to expanding upon the extensive clinical capabilities of the Surfacer System in this week's Masterclass at Charing Cross."

Gabriele Niederauer, Ph.D., CEO and President of Bluegrass Vascular, commented, "This is an exciting time for our company and for patients everywhere suffering from the devastating effects of chronically occluded veins. I am appreciative of the clinical efforts being made by leading clinicians to substantiate its clinical value and look forward to announcing the highly anticipated results of our IDE study in the U.S."

The Surfacer System will also be highlighted during the following educational sessions:

"Central Occlusion Vascular Access Masterclass 'Inside-Out''" presented by Dr. Gilbert on Wednesday, April 17thfrom 9:00am – 4:00pm BST.

The "CX Vascular Access Workshop" demonstrated by Gürkan Sengölge, M.D., Medical University of Vienna, Department of Medicine III, Division of Nephrology and Dialysis on Thursday, April 18th from 10:00am – 4:00pm BST.

The Surfacer System is CE-Mark approved and nearing completion of its pre-market investigational device exempt (IDE) study, SAVE-US (Surfacer® System to Facilitate Access in VEnous Occlusions – United States).

Source: https://www.tctmd.com/news/surfacerr-inside-outr-access-catheter-system-be-featured-2019-charing-cross-cx-international

April 16th 2019

Xenex Disinfection Services has struck a major deal with an international pharmaceutical company, which could be a precursor to a larger pharmaceutical play by the Alamo City biotech.

The deal is the result of a multiyear evaluation of Xenex’s LightStrike germ-zapping robots for use in contamination control in live production cleanrooms by one of its international distribution partners, RevDesinfectie Robots. The results of that testing have led one of the world’s largest pharmaceutical companies to buy Xenex robots for use in five of its facilities in the U.S. and Europe. Xenex could only disclose that its newest client is a Fortune 500 company.

"This is the initial contract with this particular pharmaceutical company, and we are optimistic that their program is going to grow," Xenex CEO Morris Miller said.

To date, more than 450 health care facilities in the U.S. and abroad have bought Xenex robots, which use pulsed xenon to create intense flashes of germicidal ultraviolet light that quickly destroy bacteria, viruses, mold, fungus and spores. RevDesinfectie Robots was familiar with Xenex’s technology, as its exclusive distributor in the Netherlands, Belgium and Luxembourg.

"They led the charge on the validation," Miller said.

"We strongly believe that the LightStrike technology is a breakthrough in the field of environmental disinfection, first in health care facilities and now for cleanroom contamination control," RevDesinfectie Robots’ Eric Hesp said.

Dr. Mark Stibich, co-founder of and chief scientific officer for Xenex, said the company’s migration into pharmaceutical cleanrooms is a milestone.

"This is the first time the technology has been evaluated in a manufacturing environment," he said. Miller suggests the sky is the limit in terms of this latest win.

"The pharma industry is extremely attractive because of its size and the impact we can have on their manufacturing capabilities," he said. "There are thousands of cleanrooms around the world, and we believe we can become the new standard for enhanced disinfection."

Source: https://www.bizjournals.com/sanantonio/news/2019/04/11/san-antonio-robot-maker-gains-entry-to-big-pharma.html

April 11th 2019

The technology by the Texas-based infection prevention company is designed to disinfect rooms in four or five-minute cycles

Recognising the potential of new technology for enhanced contamination control in cleanrooms where pharmaceuticals are made, RevDesinfectie Robots recently evaluated Xenex Disinfection Systems’ pulsed xenon ultraviolet (UV) light disinfection robots in live production cleanrooms.

As a result of the successful testing, one of the world’s largest pharmaceutical companies purchased and deployed Xenex LightStrike Germ-Zapping Robots to decontaminate and disinfect cleanrooms in five of its facilities in the US and Europe.

"We strongly believe that the LightStrike technology is a breakthrough in the field of environmental disinfection, first in healthcare facilities and now for cleanroom contamination control,” said Eric Hesp, spokesperson for RevDesinfectie Robots.

"The LightStrike robot was tested over multiple years for its ability to impact common cleanroom microorganisms while maintaining cleanroom compliance and the results were outstanding, which led to its adoption by a major pharmaceutical company."

Flashing pulsed xenon
More than 450 healthcare facilities around the world use LightStrike robots for room disinfection as part of their infection prevention programme.

LightStrike robots utilise pulsed xenon to create intense flashes of germicidal ultraviolet (UV) light that quickly destroys bacteria, viruses, mould, fungus and spores.

A portable unit, LightStrike robot has been designed to disinfect rooms in four or five-minute cycles (depending on the robot model) without warm-up or cool-down times.

Global market research
RevDesinfectie Robots, the exclusive distributor of LightStrike robots in the Netherlands, Belgium and Luxembourg (Benelux), facilitated testing of the LightStrike robots in cleanrooms during a two-year period.

First, in partnership with a global pharmaceutical company, they conducted over 150 evaluations to confirm the decontamination efficacy of the robot.

The initial study was followed by usability testing and workflow analysis in actual production cleanrooms. Findings validated the LightStrike robots for cleanroom use, confirming that they were effective at bringing down contamination levels within the cleanrooms.

Protocols for routine use were developed and analysed as well as a complete cleanroom validation package.

"The use of our technology to disinfect pharmaceutical cleanrooms is an exciting validation of the LightStrike robots in a new industry," said Dr Mark Stibich, co-founder and Chief Scientific Officer for Xenex.

Pointing out that the efficacy of our LightStrike robots in destroying germs and bacteria in hospitals has been proven in numerous studies, Stibich noted this is the first time the technology has been evaluated in a manufacturing environment.

"Using LightStrike robots to provide additional assurance in its cleanrooms will enable pharmaceutical companies to maximise the utilization of their cleanrooms," he said.

LightStrike robots have been studied extensively in the hospital environment and credited in numerous peer-reviewed, published studies with helping hospitals decrease their Clostridium difficile (C. diff), Methicillin-resistant Staphylococcus aureus (MRSA) and surgical site Iinfection (SSI) rates ranging from 46%-100%.

Xenex Disinfection Systems is backed by well-known investors that include EW Healthcare Partners, Piper Jaffray Merchant Services, Malin Corporation, Battery Ventures, Tectonic Ventures, Targeted Technology Fund II and RK Ventures.

Founded by three experienced businessmen who have supplied hi-tech medical equipment and information systems to healthcare facilities in the Netherlands, Belgium and Luxembourg for more than two decades, RevDesinfectie Robots is focused on supplying hospitals with the best disinfection system available to enhance patient and healthcare worker safety.

Source: https://www.cleanroomtechnology.com/news/article_page/RevDesinfectie_deploys_Xenex_LightStrike_robots_in_pharma_cleanroom/153651

April 10th 2019

KLAS Research, a healthcare IT data and insights company, recently interviewed healthcare facilities about their infection control initiatives, with a focus on innovative technologies (UV disinfection equipment, electronic hand-hygiene monitoring, and infection control software). KLAS researchers reported that Xenex LightStrike™ Germ-Zapping Robots™ earned the highest marks from hospitals for ultraviolet (UV) disinfection technology.

KLAS spoke with infection prevention professionals at 57 provider organizations to learn what approaches (and what vendors) are generating interest, which show the potential to deliver results, and what innovative tools organizations are looking to adopt. According to the report, Infection Control 2019: An Early Look at Innovative Technologies, among the UV disinfection vendors, "Xenex generates the most (and the most positive) mindshare—in part because they share research-validated outcomes—and they are the only vendor with interviewed customers who want to expand their machine fleet." Xenex was identified as having the most positive feedback due to innovation, outcomes, and ease of use.

The report states: "Xenex is one of the most well-known UV-disinfection vendors. Provider organizations who consider the vendor’s equipment do so because of Xenex’s innovative technology, ease of use, and research-validated positive outcomes. Also, Xenex is the only vendor to have current customers mention wanting to expand their machine fleet."

Irene Hahn, vice president of sales and account management for Xenex, said, “We are honored to be recognized by KLAS and the hospitals surveyed for our innovation and outcomes. There is a lot of noise in the no-touch UV disinfection space. Xenex has always believed the voice of the customer is the best indicator of our success and areas where we can improve. We are completely focused on helping healthcare facilities reach their infection rate reduction goals by working with and enhancing their existing infection prevention bundle and best practices."

As superbugs such as Clostridium difficile (C.diff), Methicillin-resistant Staphylococcus aureus (MRSA), and Vancomycin-resistant enterococci (VRE) become more difficult to kill, hospitals are increasingly turning to Xenex’s pulsed xenon UV disinfection technology to help them keep their hospitals free of dangerous microorganisms. The robots emit intense pulses of xenon UV light to quickly disinfect rooms by destroying the microscopic pathogens that may have been missed during the manual cleaning process. Numerous healthcare facilities throughout the U.S. have credited the LightStrike robots in peer-reviewed, published studies for helping them reduce their C.diff, MRSA and Surgical Site Infection rates 46% - 100%.

About KLAS Research
KLAS is a research and insights firm on a global mission to improve healthcare delivery. Working with thousands of healthcare professionals and clinicians, KLAS gathers data and insights on software, services and medical equipment to deliver timely, actionable reports and consulting services. KLAS represents the provider and payer voice and acts as a catalyst for improving vendor performance, highlighting healthcare industry challenges and opportunities, and helping build understanding and consensus for best practices. To learn more about KLAS, go to https://klasresearch.com/home.

Source: http://www.sys-con.com/node/4383797

April 3rd 2019

Local biotech companies are crafting creative strategies to overcome obstacles and get to market faster.

One of the first moves Carole Spangler Vaughn — the new CEO of San Antonio-based Emtora Biosciences, formerly called Rapmycin Holdings Inc. — made was to recommend changing the drug development company's name so that more people will know what it is and what it does.

"The first thing I noticed was the name," she said. "It sounded like a finance company or a shell company."

Spangler Vaughn gave everyone across the company, including its scientific team, a homework assignment: Come up with a new name.

"As a startup, we didn’t have the money to go out and get somebody to do this,” she said. The rebranding as Emtora Biosciences is intended to let “investors and media all know what we are."

With the name change comes a shift in focus. Before the rebranding, Emtora had launched a Phase 1b clinical trial with its initial therapeutic compound, eRapa, focusing on patients with early-stage prostate cancer. The new CEO believes the company will find a more expeditious and less costly path to market by targeting the treatment of familial adenomatous polyposis, a genetic disease characterized by cancer of the large intestine.

That could qualify Emtora, which is still years from commercialization, for an orphan drug designation for eRapa, creating a less cost-prohibitive path to market with greater competitive protection.

Emtora is among several local biotechs seeking creative ways to pave faster roads to market and more visibility in it.

To put its bioscience industry on par with major biotech hubs such as Boston and San Diego, San Antonio needs to attract more funding from investors and build more critical mass. And it needs more companies that have planted their flags in the Alamo City to find clearer paths to commercial success.

Finding the funding
Another relatively young San Antonio biotech, bioAffinity Technologies, is working to commercialize its initial product, CyPath Lung, an early cancer detection diagnostic. Despite its progress, there are local hurdles.

"Funding is the most pressing challenge for most growing firms, and it is most difficult for biotech companies," bioAffinity CEO Maria Zannes said. "San Antonio lacks that investment pool."

BioAffinity is conducting a test validation trial for CyPath Lung. It hopes to take its first product to market later this year.

In the meantime, the company has formed a scientific and medical advisory board to provide independent advice on its research and development of cancer diagnostics and therapeutics. Zannes said the level of expertise the board brings will help the company recruit more top researchers and clinicians.

StemBioSys, one of San Antonio’s more promising biotechs, has created some important momentum in its more than six years in business. The company, which develops cell-expansion technology, only had one product on the market as of November 2017. By the end of this year, StemBioSys expects to have more than a dozen products in the commercial pipeline.

StemBioSys CEO Bob Hutchens said one thing the Alamo City bioscience industry needs to build more critical mass is additional infrastructure.

"We need to continue to build the ecosystem that supports bioscience," he said. "The biggest single challenge I see is the availability of appropriate incubator and transition space for new and emerging companies in the bioscience industry. The city has a particular need for additional laboratory space to support leading-edge research."

And like Zannes, Hutchens counts access to funding among the biggest challenges.

"We will need to ensure that there is sufficient funding available to launch and build companies in San Antonio. More institutional venture capital and private equity funds are key to meeting this need," he said.

StemBioSys' challenge, he said, has been to find the right balance between a broad pursuit and a focused approach.

"This is particularly important given our need to use our financial resources very carefully," he said.

Two can play the name game
Emtora is not the only San Antonio-based biotech that has called changed course to improve marketability and expand opportunities.

Inventa BioTech Inc., which had been called CytoBioscience since it moved to San Antonio from Germany in 2015, changed names and leaders in February. James Garvin, who oversaw the company’s move to San Antonio, stepped down as CEO to become its consultant, while Steven Charest stepped in as interim CEO.

"I got the company to a particular point, and now we need to get it to the next level," Garvin said. "To move from a very tiny private company to a much bigger public company is a damned big job."

Before the name change, Inventa BioTech (OTC: INVB) completed a complex transaction that resulted in it being publicly traded.

Garvin said the company must expand its commercial base and look for more “acquisition opportunities” as it moves forward.

Shouting out the victories

There have been some success stories in San Antonio.

Xenex has marketed its germ-zapping robots to hundreds of hospitals and other medical facilities across the world looking to reduce patients’ exposure to potentially lethal health care associated infections.

San Antonio is also home to BioBridge Global, a nonprofit that’s provided a big boost to the city’s efforts in regenerative medicine through its multiple subsidiaries, including GenCure. The BioBridge Global GenCure Biomanufacturing Center will anchor a new VelocityTX innovation hub planned for the old Merchants Ice warehouse on East Houston Street, establishing a presence closer to San Antonio’s military medical activity at Fort Sam Houston.

"San Antonio has great potential that has yet to be realized, but I think we have the ingredients to reach greater success," Zannes said.

Garvin believes San Antonio can compensate for some of its lack of investment support with greater self-promotion.

"First and foremost is to understand that San Antonio is already a world leader in biotech and bioscience,” he said. “San Antonio is a place where leading companies are, where leading technology is emerging."

His advice for Alamo City leaders: "Acknowledge it. Shout it out to the world. Stop being a secret. Thump your chest and be darn proud. When you do that, the world will see San Antonio far differently."

Zannes said San Antonio's intangible is the collaborative support from various institutions, including the University of Texas at San Antonio and UT Health San Antonio.

StemBioSys’ Hutchens is among the believers.

"We are starting to see a number of our startup companies begin to build market presence and expand their footprint here in the U.S. and globally," he said.

Emtora’s Spangler Vaughn's main goal is to get the company’s first drug “across the finish line.” And she sees no reason that can’t happen in San Antonio.

"People are energized," she said. "People are happy to see that someone who has done this before has chosen a San Antonio company to work with."

Source: https://www.bizjournals.com/sanantonio/news/2019/03/22/local-biotech-companies-work-to-navigate-the-maze.html

March 22nd 2019

As a part of my series about “The Future of Healthcare” I had the pleasure of interviewing Morris Miller. Under Morris Miller’s leadership, Xenex has become a world leader in automated room disinfection. Through the use of xenon technology and innovative hospital disinfection protocols, the company is helping healthcare facilities achieve significant infection reduction results. As CEO, Morris is responsible for the company’s overall business strategy and oversight of day-today operations. Originally from San Antonio, Morris is a graduate of the Dedman School of Law at Southern Methodist University, The University of Texas at Austin, and Phillips Exeter Academy. He is the founder of Sequel and Cutstone Ventures, which invests in/acts as an advisor to numerous start-ups such as Inventables, Adometry, and Golfballs.com. He started Curtis Hill Publishing, the first company to publish Texas case law on CD-ROM, and he was also the co-founder and President/CEO of Rackspace (NYSE: RAX). Morris is a member of APIC and BioMed SA.

Can you tell us a story about what brought you to this specific career path?
I started my career as an attorney at a law firm, and launched a company that was the first to publish Texas case law on CD-Rom. After selling the publishing company to Thomson Reuters, I wrote the first check and co-founded Rackspace. Eventually I started my own venture capital firm, which brought me to Xenex.

When the Xenex founders approached me about their Germ-Zapping Robot technology, I consulted with my father, a retired physician who specialized in Internal Medicine, about the technology’s potential. I was shocked when he told me that being able to stop healthcare associated infections could have more of an impact on humanity than his service to his patients throughout his entire career. The Xenex founders, Dr. Mark Stibich and Dr. Julie Stachowiak, had a focused mission?—?to stop the needless pain and suffering and over 100,000 annual deaths caused by healthcare associated infections, which was something I was proud to get behind and help grow.

Can you share the most interesting story that happened to you since you began your career?
I’ve been fortunate to meet some incredibly smart people and invest in a variety of exciting technologies. A story that resonates with me is one that happened recently where we were able to convince a skeptical Infectious Disease doctor about the efficacy of our LightStrike robots.

I think it’s important to understand the enormity of the epidemic facing healthcare facilities today. Nearly 100,000 people die in the U.S. every year from healthcare associated infections. That is more than 300 people dying every day from an infection they acquired during their hospital stay. Everyone knows someone who went to the hospital to have a hip or knee replaced, seek treatment, or have a baby, and contracted a scary (and sometimes deadly) infection. These infections are caused by microorganisms like C.diff (Clostridium difficile), MRSA (Methicillin-resistant Staphylococcus aureus), and CRE (Carbapenem-resistant Enterobacteriaceae) that remain on hospital surfaces, even after a room has been cleaned. They linger on tray tables, bedrails, doorknobs, OR equipment, wheelchairs, and IV poles. Some of the really scary ones?—?like C.diff?—?can live on surfaces for up to 5 months. It’s happening every day. Hospitals need more than 2 hours to properly disinfect a hospital room with traditional methods, but the germs that make people sick are becoming resistant to cleaning chemicals and antibiotics. In addition, financial pressure only allows hospitals to give cleaning team members 28–45 minutes to get the room ready for the next patient, which is a 2+ hour job (for proper disinfection).

That’s what is so frightening?—?the germs have become resistant to antibiotics and we don’t have the time to properly disinfect the rooms or the drugs to treat the diseases they cause.

Back to my story. Peer-reviewed outcome studies published in journals are the gold standard in the medical device world. I visited an Infectious Disease doctor at a world renowned hospital and I presented 4 peer-reviewed outcome studies from hospitals that saw their infection rates plummet after they added our LightStrike room disinfection technology to their cleaning protocols. The doctor crossed her arms and succinctly told me “I don’t believe you.” Despite the evidence, she didn’t believe that our robots could kill the germs that make people sick and help bring down the facility’s infection rates. She was willing to give the LightStrike technology a chance, however, because other interventions weren’t working. Nine months later, she conducted her own independent, controlled trial. The results, which were recently published in the American Journal of Infection Control, showed that C.diff infection rates fell 47% on the units where our robots were used for room disinfection. C.diffinfection rates INCREASED on the units that were not disinfected with our robots. The hospital deployed 12 robots and have continued to see reductions in their infection rates. While the story has a happy ending, it feels like we have to repeat the same process in every hospital.

Can you tell us about your “Big Idea That Might Change The World”?
Antibiotic resistance is responsible for the deaths of 700,000 people each year. That number is expected to skyrocket to 10 million deaths by 2050 unless action is taken. These deaths are caused by antibiotic resistant pathogens?—?like methicillin resistant staph and vancomycin resistant enterococci (VRE). We no longer have antibiotics to treat the infections they cause. The only way to combat this epidemic is to reduce the number of cases where antibiotics are needed. If you destroy the pathogens before they are transmitted to people, then infections are prevented. It’s a paradigm shift in the way we think about antibiotic resistance and superbugs. Kill the pathogens before they make people sick and then you don’t need antibiotics to treat the infections.

And that’s what LightStrike Germ-Zapping Robots accomplish. The robots use intense pulsed xenon ultraviolet (UV) light that quickly destroys pathogens so they can’t reproduce, mutate or cause infections. The robots are operated by a hospital’s cleaning team and have been proven effective against the most dangerous microorganisms (like Ebola and anthrax) as well as the most common (MRSA, influenza). Hospital employees still clean the rooms?—?remove trash and visible dirt/fluids, change the linens?—?and then they bring in our robot to destroy any pathogens that you can’t see but may have been missed during the manual cleaning process. Right now we are focused on healthcare?—?hospitals, surgery centers, long term acute care facilities and skilled nursing facilities, but there are certainly other places where our robots could have an impact (professional sports locker rooms, cruise ships, airports, etc.).

How do you think this will change the world?
Our mission is to stop the deaths and pain and suffering caused by healthcare associated infections. If we can stop the infections and reduce the risk of antibiotic resistance, then we can change the world. Right now, 300 people die in the U.S. every day from an infection they got in the hospital. Hospitals using LightStrike robots are reporting 50, 75 and even 100% reductions in their infection rates. Adding LightStrike room disinfection to a hospital’s comprehensive infection prevention strategy (hand hygiene, antibiotic stewardship, etc.) will make a difference.

LightStrike Germ-Zapping Robots have run more than 17 million cycles in hospital rooms. Using CDC statistics, that means that over the past 5 years, the robots have helped hospitals prevent 340,000 infections?—?and saved 37,000 lives. Conservatively, the average cost of treating a MRSA, C.diff or surgical site infection is $11,000 (per infection), so hospitals have saved $3 billion as a result of fewer infections.

We’ve talked a little about the financial impact of infections but it’s worth repeating. Infections are devastating for the patients who suffer them, but they also can have a negative impact on a hospital’s bottom line. Preventing just a couple of infections pays for a robot. Most hospitals report ROI in just a couple of months.

There’s also the PR value, which can’t be overlooked. Hospitals are now required to report some of the infections they cause?—?such as C.diff, MRSA and some surgical site infections. Consumers can go online and check out the infection rates for the hospital where they are going. You don’t want a loved one going to a hospital with high infection rates.

Keeping “Black Mirror” and the “Law of Unintended Consequences” in mind, can you see any potential drawbacks about this idea that people should think more deeply about?

Preventing infections in a hospital requires teamwork?—?the facility’s Infection Prevention and Environmental Services (EVS) team members must work together to develop and maintain a successful Infection Prevention program. Our Germ-Zapping Robots are not replacing human jobs and they need to be part of a comprehensive infection prevention strategy. It’s a huge misconception that the robots can do the work of the hospital’s EVS team members. The robots are tools (very powerful tools!) that enable the EVS team to do a great job but they are operated by humans. Successful infection prevention requires a comprehensive strategy?—?hand hygiene, antibiotic stewardship and LightStrike room disinfection.

Was there a “tipping point” that led you to this idea? Can you tell us that story?
When we launched LightStrike robots, we were optimistic that we could help hospitals bring down their infection rates by 5–10%. I was visiting with a customer one day and their Infectious Disease doctor told me an amazing story that served as our “tipping point.” The hospital was using 2 of our robots to disinfect rooms. Based on historical trends, they expected 16 Clostridium difficile (C.diff) infections during Q1. After they began using our LightStrike robots to disinfect rooms, they only had 2 C.diff infections during that quarter?—?and those were on rooms where the robot wasn’t used!

It established that there is a direct correlation between using Xenex disinfection robots and the number of infections patients will suffer. When a hospital reduces infection rates by 5%, they have paid for the robots. That hospital experienced a 73% reduction in infections, which showed us the huge potential for the technology. We realized we needed to get LightStrike robots in hospitals ASAP.

We believe so strongly in the technology that we offer hospitals a “No Risk” program where they can evaluate our technology in their facility at no cost. We will provide robots and training for hospital employees at no cost, and then track utilization. We guarantee the hospital will see a reduction in infection rates or they can send the robots back. They only pay us when they’ve seen the agreed upon reduction in infection rates. We did this for a hospital in New Orleans and they recently reported a 70% reduction in infection rates since they have been disinfecting rooms with LightStrike robots. That facility is using 16 of our robots and has expanded the program to other facilities in their system.

What do you need to lead this idea to widespread adoption?
We need hospitals, physicians and the public (patients and their families) to realize that the majority of infections are preventable. Hospitals don’t like to talk about their infection rates because in the past they have been powerless to prevent them. Doctors want to believe that the OR where they are operating and the patient recovery rooms are properly cleaned and disinfected.

Unfortunately, the peer-reviewed studies have established that this isn’t the case. Studies have shown that less than half the surfaces in a hospital room are properly disinfected when it’s being prepared for the next patient. It may look and smell clean, but pathogens remain. Contamination exists?—?even after a thorough cleaning?—?and it’s enough to cause deadly infections. We need people to demand that the hospitals properly disinfect their rooms?—?or seek treatment elsewhere.

Remember, nobody can see these microscopic pathogens! A room that looks clean and smells clean gives the occupant a false feeling of safety.

What are your “5 Things I Wish Someone Told Me Before I Started” and why. (Please share a story or example for each.)
When we started the business, we were hoping we could help hospitals get a 5–10% reduction in their infection rates. We were astonished when hospitals began reporting greater than 50% reductions in their infection rates?—?with some experiencing more than 75% reductions. We knew the technology had the potential to make a huge difference, but we had no idea about just how enormous an impact it would have.

When we began to get traction inside hospitals, I called upon the CEO of a for-profit hospital. As I explained how the robot works and how it can be easily integrated into the hospital’s cleaning strategy, he told me that I was naïve. He said, “it’s not flattering, but we make money even when we make people sick.” Learning that hospitals profited from infections was something I never expected.

Be patient. Selling technology to healthcare facilities is complex and time-consuming. Many industries embrace innovation?—?like creating a better shopping site (Amazon.com). But in hospitals, even if you offer a technology that is statistically better than what they are doing AND it can save them money, they may still take YEARS to adopt it.

Infections happen to everyone. I thought infections only happened to elderly people or people who are immuno-compromised or weak. They can and do happen to everyone, even healthy people who are in the prime of their lives.

Patients must be responsible for their own safety. Check out the hospital where you or your loved one is going. If the hospital isn’t using pulsed xenon UV disinfection technology, then find a facility in your area that does. My sister recently needed an operation and the hospital where her doctor operates doesn’t use LightStrike room disinfection. We offered to disinfect her OR and recovery room at that hospital at no charge, but the hospital decided that they wouldn’t allow us to do it. My sister switched doctors and hospitals so she could go to a facility that properly disinfects its ORs and patient rooms.

The future of work is a common theme. What can one do to “future proof” their career?
LightStrike robots have specific functions and extraordinary capabilities but the point of care in hospitals is delivered by humans. Providing a germ-free environment is a preventive measure. What people remember is their doctor, the nurses and the people who cared for them during their hospital stay. People matter. Whether you are a doctor, lawyer, EVS team member or teacher, when you care about others then you can future proof any job.

Based on the future trends in your industry, if you had a million dollars, what would you invest in?
Most people have no idea of the risk they face when they go to the hospital. Everyone knows someone who went to the hospital to have a joint replaced, seek treatment, or have a baby?—?and unfortunately contracted a painful and sometimes deadly infection. Most people have no idea that the hospital environment?—?microorganisms that you can’t see that are lurking on bedrails, tray tables, door knobs and OR equipment?—?caused their infection. With $1 million, we would create a consumer education campaign to raise awareness about hospital acquired infections because that’s not happening today.

Which principles or philosophies have guided your life? Your career?
Always be good for nothing. Do the right thing because it’s the right thing to do, not because you expect to gain something from it.

Non-Sibi. Do everything you can to make the world a better place.

Can you share with our readers what you think are the most important “success habits” or “success mindsets”?
The most important question to ask yourself is ‘why not me’? You have to believe in yourself. When I started my first company, I was rejected 168 times before I found my first investor. Be willing to be rejected, whether it’s by an investor, customer, etc. It’s not a coincidence that the harder you work, the luckier you get.

Some very well known VCs read this column. If you had 60 seconds to make a pitch to a VC, what would you say?
My VC fund and I have invested millions of dollars in Xenex since discovering how effective the technology is. I invite similarly-minded individuals and their firms to join us in our mission?—?which is to stop the deaths and stop the pain and suffering caused by hospital acquired infections.

Many VCs sit on the boards of hospitals and foundations. They can influence hospital decision-makers to invest in room disinfection technology?—?it’s good for the patients and it’s good for the hospital’s bottom line. Stopping the infections means we can preserve the efficacy of antibiotics, and protect our children, grandchildren and future generations.

Source: https://medium.com/authority-magazine/the-future-of-healthcare-our-mission-to-stop-the-needless-pain-and-suffering-and-over-100-000-30a124fca55b

February 22nd 2019

Xenex Disinfection Services Financing
Xenex Disinfection Services Llc, Limited Liability Company just submitted form D about $6.72 million debt financing. The date of first sale was 2018-09-19. Xenex Disinfection Services was able to fundraise $6.02 million. That is 89.59 % of the offering. The total financing amount was $6.72 million. The fundraising form was filed on 2019-02-19. The reason for the financing was: The Offering is structured with multiple closings.. The fundraising still has about $700,000 more and is not closed yet. We have to wait more to see if the offering will be fully taken.

Xenex Disinfection Services is based in Texas. The company’s business is Other Technology. The form D was signed by Morris Miller CEO. The company was incorporated more than five years ago. The filler’s address is: 121 Interpark, Suite 104, San Antonio, Tx, Texas, 78216. Sequel Ventures, Llc is the related person in the form and it has address: 755 E. Mulberry Ave., Suite 450, San Antonio, Tx, Texas, 78212. Link to Xenex Disinfection Services Filing: 000155681419000001.

Analysis of Xenex Disinfection Services Offering
On average, startups in the Other Technology sector, sell 85.80 % of the total offering size. Xenex Disinfection Services sold 89.59 % of the offering. The fundraising is still open. Could this mean that the trust in Xenex Disinfection Services is high? The average financing size for companies in the Other Technology industry is $1.54 million. The total amount raised is 291.04 % bigger than the average for companies in the Other Technology sector. The minimum investment for this offering is set at $0. If you know more about the reasons for the fundraising, please comment below.

What is Form D? What It Is Used For
Form D disclosures could be used to track and understand better your competitors. The information in Form D is usually highly confidential for ventures and startups and they don’t like revealing it. This is because it reveals amount raised or planned to be raised as well as reasons for the financing. This could help competitors. Entrepreneurs usually want to keep their financing a ‘secret’ so they can stay in stealth mode for longer.

Why Fundraising Reporting Is Good For Xenex Disinfection Services Also
The Form D signed by Morris Miller might help Xenex Disinfection Services Llc’s sector. First, it helps potential customers feel more safe to deal with a firm that is well financed. The odds are higher that it will stay in the business. Second, this could attract other investors such as venture-capital firms, funds and angels. Third, positive PR effects could even bring leasing firms and venture lenders.

Source: https://www.mmahotstuff.com/2019/02/19/xenex-disinfection-services-6-72-million-financing-morris-miller-published-feb-19-d-filing.html

February 19th 2019

Gemini Bio-Products adds StemBioSys products to its portfolio

Xconomy Texas — San Antonio—The CEO of InventaBioTech, a life sciences business formerly known as CytoBioScience, is stepping down and being replaced by an interim leader.

WEST SACRAMENTO, CA and SAN ANTONIO, TX, February 11, 2019 – Gemini Bio-Products (“Gemini”) and StemBioSys are pleased to announce a strategic partnership that will bring StemBioSys’ entire selection of matrices and cells into the Gemini portfolio. Launching this week, customers will now have the ability to purchase StemBioSys’ proprietary and innovative CELLvo™ products directly from Gemini.

StemBioSys’ novel CELLvo™ matrices provide cells a home in which they can expand in a rapid yet natural way. Studies conducted by StemBioSys, its partners, and various customers over the years demonstrate that cells isolated and expanded on the CELLvo™ Matrix proliferate faster than on competitors’ products. The cells also retain their native phenotype better in comparison to the same cells grown using competitive products. StemBioSys also offers a variety of high quality cell products that are isolated and expanded on their CELLvo™ Matrix technology.

Dale Gordon, Gemini Bio-Products CEO, stated, “We’re thrilled to have the opportunity to partner with StemBioSys and believe their innovative tools and high-quality cells are the perfect complement to our existing cell culture portfolio. Additionally, we plan to leverage each other’s unique competencies and networks to identify unmet market needs in order to accelerate product development for both organizations. We believe this partnership is a critical step for us as we strengthen our position in the Cell and Gene therapy space.”

Bob Hutchens, StemBioSys President and CEO, added, “We are very excited about our new partnership with Gemini Bio-Products. Our respective product lines, capabilities, and company cultures complement one another perfectly. We believe that there is a tremendous upside for both Gemini and StemBioSys in this partnership. The entire StemBioSys team and I look forward to working with Gemini Bio-Products in the years ahead.”

StemBioSys has plans to release nine additional CELLvo™ cell culture products over the course of 2019. Upon launch, Gemini will also offer these new products for purchase.

About Gemini Bio-Products
Founded in 1985, Gemini is a supplier of cell culture media, sera, and other reagents to many of the world’s top research and academic communities, biotechnology firms, and pharmaceutical companies. Today, Gemini operates from a 14,000 square foot manufacturing facility in West Sacramento, California. A national sales force and an international distribution network serves cell culture laboratories worldwide.

Source: https://www.stembiosys.com/news/2019/2/11/gemini-bio-products-and-stembiosys-announce-strategic-partnership

February 11th 2019

Xconomy Texas — San Antonio—The CEO of InventaBioTech, a life sciences business formerly known as CytoBioScience, is stepping down and being replaced by an interim leader.

Jim Garvin, who has been the CEO of Inventa since March 2015, shortly before it moved to San Antonio, TX, from Germany, will remain an active contributor to the business, he wrote in an e-mail this morning. Garvin’s responsibility was to establish Inventa in the U.S. and get it onto a “public platform,” he wrote. Steven Charest, a New York investment banking executive, is taking over as the interim CEO.

Last year, when the San Antonio business was still known as CytoBioScience, it went through a reverse merger with Fort Collins, CO-based WestMountain Company, which was traded on the over-the-counter public markets. After rebranding as InventaBioTech, the business is now traded under the symbol INVB with OTC Markets Group.

“Taking the company far beyond that requires great skills, lots of energy, and tremendous amounts of time,” Garvin wrote in the e-mail. “At 71, I can still be an active contributor and will (be), but this is the time for a new person to take the helm.”

As Charest takes over, Garvin will remain a consultant with the business until at least 2021, the San Antonio Business Journal first reported and Garvin confirmed this morning. Charest is the chief market strategist and a managing director of Divine Capital Markets, a New York-based broker-dealer focused on investment banking services and equity research.

Garvin also previously worked at Divine Capital Markets for almost two years prior to joining Inventa in 2015, which may be the connection to Charest, who has worked at Divine since 2003, according to their LinkedIn profiles. Charest said he wasn’t immediately available for comment. Divine is listed as receiving sales compensation in a March 2018 regulatory filing related to Inventa’s intended merger.

Inventa sells a device, the CytoPatch, for screening the safety and efficacy of drug formulations, and it also provides contract research services. Its contract research accounted for most of its revenue during the first three quarters of 2018: $562,000, according to a securities filing. Equipment sales totaled $188,000 during that period, the filing shows.

Most of those sales came during the third quarter of last year: about $582,000 in equipment and contract research sales took place in the three months that ended Sept. 30. The company recorded only $168,000 in revenue from equipment sales and contract research during the first half of the year, according to the securities filing. It ended the first nine months of 2018 with a $3.77 million net loss, the filing shows.

Founded in 2001 in Germany, CytoBioScience was lured to San Antonio in 2015 by venture capital money and government incentives. The company has raised $15.8 million from some 11 investors since 2015, including San Antonio-based firm Targeted Technology, according to a regulatory filing. The city of San Antonio promised to give the company as much as $1 million for moving here, creating jobs, and investing around $15 million in making the Alamo City its headquarters. The city provided the startup with $500,000 of the money in 2015, and the business returned $100,000 of it in 2016, according to a securities filing.

Inventa and the city of San Antonio decided to terminate the agreement in April 2018, with the company agreeing to repay the remaining $400,000 it had received during a two-year period—with the first payment due in September, the securities filing shows. Inventa is in default with the agreement and negotiating with the city on potentially adjusting the deal, the filing says.

Source: https://xconomy.com/texas/2019/02/07/inventa-biotech-formerly-cytobioscience-replaces-ceo/

February 7th 2019

The San Antonio-based company formerly known as CytoBioscience is making major changes, including leadership and branding, as it looks to grow and diversify its business supporting drug development and research.

CEO James Garvin — who oversaw the biotech’s move here from Rostock, Germany, in 2015 and subsequent expansion — is stepping down. And the company will have a new name, InventaBioTech Inc. (OTC: INVB), to go with a new chief executive.

Steven Charest, who is managing director of New York-based Divine Capital Markets, will be interim CEO. Garvin will remain with Inventa in a consulting role until at least 2021, initially supporting Charest.

“I got the company to a particular point, and now we need to get it to the next level,” Garvin said. “To move from a very tiny private company to much bigger public company is a damned big job. It was time for this to happen.”

One of Charest’s main priorities will be to help raise more capital for the company. Another will be to align its personnel and strategies to prepare for life as a public company with an eye on more potential acquisitions.

“Our plan is to have a full-time CEO with experience in running a public company and all the issues that come with that,” Charest said. “In the meantime, we need to have someone to work on the transition day to day.”

That transition could include some restructuring and more hiring, Charest said.

In March 2018, CytoBioscience acquired, through merger, a subsidiary of WestMountain Co. That move set the stage for CytoBioscience’s pivot from private to public. The company followed that deal by buying a Birmingham, Alabama, company — BioDtech Inc. — late last year.

Charest said there could be more transactions to come.

“Steve and I have known each other for a long time. We have a lot of trust in one another,” Garvin said. “So this is a very solid transition process. We’ve talked a lot about the changes that are necessary now as we go to the next stage. We are very much on the same page.”

One thing that's not changing is the company's address.

“The company is not going anywhere. It’s staying right here,” Garvin said. “I love this company, and I love San Antonio.”

Source: https://www.bizjournals.com/sanantonio/news/2019/02/07/sa-biotech-gets-interim-ceo-as-it-rebrands.html?ana=e_mc_prem&s=newsletter&ed=2019-02-07&u=SZ%2BvXk14LqZDaLbelLeOyQ0055c364&t=1550495496&j=86520251

February 7th 2019

SAN ANTONIO – StemBioSys Inc. announced today that they have co-authored a paper which has been published in the peer reviewed journal Acta Biomaterialia on an innovative use of its technology. The company also announced expansion of their product offerings and outlined its product development plans for 2019.

The paper that was recently published in Acta Biomaterialia described how a new version of the company’s core matrix technology supports the expansion of large numbers of human articular chondrocytes while maintaining important characteristics of these cells.

The underlying research project was conducted in collaboration with the New Jersey Center for Biomaterials at Rutgers University (NJCBM) under the leadership of Dr. Joachim Kohn. Dr. Yong Mao, also from the NJCBM, was instrumental in working with SBS researchers on this study.

StemBioSys President & CEO, Bob Hutchens, noted that this was the first publication that described a use of the company’s proprietary technology for articular chondrocytes. Hutchens further explained that the work is distinctive because chondrocytes are the regenerative cells for cartilage tissue.

“As our population ages, the number of people who may need cartilage tissue repair increases dramatically,” Hutchens said. “Our technology might ultimately be used in these cartilage repair treatments for patients.”

He noted that there is still much work to be done before this technology can benefit human patients. As a first step toward developing this technology, the company has submitted a government grant application to support further development of the methods and technology.

“The publication in Acta Biomaterialia is important because it provides confirmation that our science is valid and our technology has meaningful therapeutic applications” explained Dr. Sy Griffey, the company’s Chief Operating Officer. “We are looking forward to continuing our work – ideally with government support”.

Separately, the company announced that over the last several months it has introduced four new cell products into the research market. These cells have been isolated and expanded using StemBioSys’ platform matrix technology, thereby differentiating them from similar stem cells available to the research market. Three of the cell products are stem cells from various human tissue sources. The company also announced a chondrocyte cell product to support researchers doing work in cartilage repair. Hutchens noted that early sales of these cells to researchers have been very encouraging.

Finally, the company announced today that it plans to more than double its product offerings over the next 12 months.

”Today, we have seven different products on the market,” Hutchens said. “We are on track to have an additional nine products on the market by the end of 2019. It is going to be an exciting year for StemBioSys.”

Source: https://www.stembiosys.com/news/2019/1/29/stembiosys-kicks-off-2019-with-peer-reviewed-technology-article-product-development-and-product-expansion-plans

January 29th 2019

San Antonio-based StemBioSys Inc., which develops and manufactures advanced stem cell technologies for researchers in regenerative medicine, added four cell products to its portfolio in recent months, taking its inventory to seven products. Its plan for 2019 is far more ambitious, as CEO Bob Hutchens told the business journal in an exclusive interview that the company expects to develop and market nine additional cell products this year.

That’s a far cry from where StemBioSys was when it launched in 2010 — or when Hutchens became CEO in 2014.

“In November 2017, we had one product,” Hutchens said.

By 2020, StemBioSys expects to have 16 products on the market, and potential investors are taking note.

“There is a high-level interest,” Hutchens said. “We can meet with anyone we want to now. It doesn’t mean they are going to write a check. But it means they are at least interested in the technology.”

StemBioSys has built relationships with nearly a half-dozen New York banks. It’s also pursuing more collaborative opportunities with potential partners. Hutchens said StemBioSys is in discussions about a deal that arose from one its banking relationships and could be finalized in a few weeks.

“It would involve access to markets,” Hutchens said.

Such opportunities for growth spur a need for more capital to add talent and infrastructure. StemBioSys plans to launch a Series C funding round in February with an initial goal of $3 million, and the company could raise twice that amount.

However, mixed with optimism is a realization among StemBioSys leaders that some factors that could affect business are of their hands. The United Kingdom’s intention to leave the European Union, for example, could affect part of StemBioSys’ distribution network.

“We have a great distributor in the U.K. Our concern is how BREXIT could impact them,” Hutchens said.

But even that distraction hasn’t tempered expectations.

“There has been a lot of recognition of what we have done and of what our plans are for 2019,” Hutchens said. “This is a different company than what it was 18 months ago. We are beginning to mature. We have a clear vision for where we are going.”

Source: https://www.bizjournals.com/sanantonio/news/2019/01/29/sa-biotech-looks-to-expand-itsproducts-through.html

January 29th 2019

When germ-zapping robots were first introduced at Unity Health in January 2017, the overseers of the Xenex program feared hesitancy to embrace it due to the fact that this step adds a minimum of 15 minutes to the cleaning process. However, once the numbers came back, no one had any doubts about it.

Unity Health infection preventionists Meghann Holmes and Samantha Green, who have been over the program since its beginning, said that it has succeeded because of teamwork.

“It takes everyone,” Holmes said. “Environmental Services is the main component because they are the ones using them every day. I have been so impressed with their willingness and effort. I am so pleased that none of them seem to mind having an increase in their workload because they know they are making the hospital a safer place for our patients.”

The goal of the Xenex Lightstrike Germ-Zapping Robot Program is to create an overall safer environment for not only the patients, but also family and loved ones who visit. These robots use a powerful pulsed xenon light to kill harmful viruses and bacteria that can cause health-care-associated infections such as methicillin-resistant Staphylococcus aureus (MRSA), Clostridium difficile (C. diff) and the influenza virus.

Unity Health was the first hospital in the state to implement the program. It currently has germ-zapping robots in four nursing units and in the operating room. They are also used to disinfect additional work spaces like break rooms and medication rooms. The Infection Prevention and Environmental Services departments hope to eventually have a robot for each unit at the hospital.

Former Unity Health Chief Medical Officer Dr. John Henderson first saw the Xenex program elsewhere. He heard about the success had with it, then presented the program to Infection Prevention to get the department’s take on the technology.

“Dr. Henderson was our champion and driving force for implementing the Xenex program,” Holmes said. Holmes re-emphasized that successfully implementing the program would not have been possible without everyone being on board and doing their part — the nursing staff that manages timely discharges and troubleshooting, the biomed team that provides timely maintenance and ensures the robots are working correctly and the administration team that supports the implementation of the program.

The Infection Prevention department monitors all the data, including infection rates, robot usage and protocol compliance, which the department reports on monthly. This allows the department to see how many health-care-associated infections (HAIs) the hospital has decreased by.

Here are some of Unity Health’s accomplishments with the Xenex program:

• 71 percent decrease in HAIs (December 2017-August 2018);
• Estimated over $700,000 in cost savings;
• 22 infection cases avoided in patient floor units;
• 7 infection cases avoided in the operating room;
• Unity Health’s New Life Center and Observation unit have been recognized for 1,000 days with no HAIs;
• Steve Cooper, biomedical technician, named Xenex Technician of the Quarter.

The Xenex program is part of the Unity Health Foundation campaign Home is Where the Heart Is. Campaign funds help to provide new Xenex robots, Inpatient Physical Rehabilitation Center renovations and Patient Safe Handling Rooms. To learn more about the campaign or to donate, visit www.unity-health.org/foundation or call the Unity Health Foundation at (501) 278-3191.

Source: http://www.thedailycitizen.com/news/news.php?ID=13748

January 15th 2019

Riverside Medical Center's two automated disinfection systems helped to reduce ICU infection rates

Riverside Medical Center is known for its commitment to patient care, and has received many accolades attesting to the organization’s capabilities. The medical center is part of a fully integrated health care system serving patients throughout the Illinois counties of Kankakee, Iroquois, Will, Grundy and beyond.

Riverside Medical Center provides a full scope of inpatient and outpatient care and is a nationally recognized, award-winning Level II trauma hospital with nationally leading programs in heart care, cancer care, neurosurgery and orthopedics.

The 312-bed hospital is a nine-time recipient of the Watson Health Top 100 Hospitals designation, has earned Magnet status from the American Nurses Credentialing Center’s Magnet Recognition Program and is a Truven Health 50 Top Cardiovascular Hospital.

The medical center’s numerous recognitions are borne from its commitment to continuous self-improvement, and that commitment isn’t limited to clinical care. In fact, Riverside Medical Center boasts low health care-associated infection rates and recently has turned to advanced technology to drive those numbers even lower.

As hospitals look for new and innovative ways to battle deadly pathogens and kill multidrug-resistant organisms that can endanger patients and hospital employees, Riverside Medical Center invested in state-of-the-art room disinfection robots to stop superbugs in their tracks.

The medical center chose Xenex’s patented Full Spectrum, pulsed xenon ultraviolet (UV) room-disinfection system for many reasons, including its speed and ease of use. Now considered part of the hospital’s environmental standard of care, the robots’ work is paying off.

Since deploying two Xenex LightStrike Germ-Zapping Robots, Riverside has seen 27 percent reductions in Clostridium difficile, methicillin-resistant Staphylococcus aureus and Vancomycin-resistant enterococci rates facility wide, and a 65 percent reduction in infection rates in its intensive care unit.

“The microorganisms that cause infections are getting smarter and becoming antibiotic-resistant, which is why we need new weapons like the LightStrike robot to destroy them before they pose a threat to patients and our employees,” says Martha Bouk, infection preventionist at Riverside Medical Center.

“Riverside already had very low infection rates, but our goal is zero infections,” she continues. “I am proud that since we implemented two Xenex robots, we have seen significant infection-rate reductions. Use of the LightStrike system enhances the hospital’s already thorough processes for cleaning rooms and killing the pathogens that cause infections. We want to go above and beyond for our patients, and the two disinfection robots are helping us take cleanliness to the next level.”

The LightStrike Germ-Zapping Robots can disinfect an entire patient room in 20 minutes or less. Users can access comprehensive reports from a cloud-based system to track their use and ensure consistent protocol.

Riverside’s environmental services team uses the two portable robots, named Albert and Clean Victoria, to disinfect more than 30 rooms per day in its intensive care unit, pediatric floor, medical-surgical unit and operating rooms.

The robots emit intense pulses of xenon UV light to quickly disinfect rooms by destroying the microscopic pathogens that may have been missed during the manual cleaning process. Since deploying the two robots, Riverside Medical Center has earned another accolade as a Xenex Visionary Hospital in recognition of its innovation and success in infection prevention and outstanding patient care.

These Visionary Hospitals are recognized for their efforts to make patient safety a top priority; seek and implement technologies with multiple proven outcomes published in peer-reviewed publications; follow manufacturer-recommended best practices; publicize and share results to improve best practices for all hospitals; and openly share their data for public benefit.

Source: https://www.hfmmagazine.com/articles/3540-hospital-uses-robots-to-fight-infection

January 9th 2019