First-ever published 12-month results from Level 1 intradiscal study for treating patients with one or two level symptomatic degenerative disc disease

Early evidence suggests greater than 70% reduction from baseline in pain in Visual Analog Scale (VAS) and functional improvement measured in Oswestry Disability Index (ODI) that is sustained at 12 months in allogeneic disc tissue treatment groups

ATLANTA and MIAMI, April 30, 2020 /GlobeNewswire/ –

VIVEX Biologics, Inc., a leading regenerative medicine company specializing in the development of naturally sourced treatment options, today announced that the initial clinical trial results of VIVEX’s VAST Trial evaluating VIA® Disc were published in the peer-reviewed journal The International Journal of Spine Surgery. The paper was the first-ever published 12-month results from Level 1 intradiscal study for treating patients with one or two level symptomatic degenerative disc disease (DDD). VIA Disc is a non-surgical, injectable treatment option for patients suffering from chronic lower back pain resulting from DDD.

The paper, titled, VAST Clinical Trial: Safely Supplementing Tissue Lost to Degenerative Disc Disease, by Beall, et. al., reported initial results from the 24-patient safety cohort of VIVEX’s VAST Trial evaluating the safety and performance of VIA Disc. Data demonstrate that VIA Disc improved pain and function in patients with DDD by greater than 70%, as measured by visual analog scale (VAS) and Oswestry Disability Index (ODI), and that these improvements were durable one-year after the procedure.

“I am highly encouraged by the initial results and safety data from the VAST study. Implantation of disc tissue allograft can be done safely, and early evidence suggests greater than 70% improvements in VAS and ODI sustained at 12 months in the allograft groups,” said Douglas Beall, MD, chief of radiology services at the Clinical Radiology of Oklahoma and principal investigator of the VAST study. “Interventions like VIA Disc have the potential for treating mild-to-moderate degenerative discs that greatly advance an alternative to surgical intervention.”

Lower back pain is the most expensive occupational disorder in the U.S. and is the leading cause of disability globally. DDD is a major factor contributing to this disability and is the most common etiology of chronic lower back pain in adults. Low back and neck pain in the U.S. were the third-largest condition of spending in 2013, with estimated health care spending of $87.6 billion. Today, there are limited treatment options, including progression to opioids and surgery for patients who fail non-surgical management.

To address this gap in the continuum of care, VIVEX developed VIA Disc to offer patients a novel, non-surgical intervention for treating one to two levels of symptomatic DDD.

Peter Wehrly, chief executive officer of VIVEX, stated, “These results provide further validation of the therapeutic potential VIA Disc may offer patients in critical need of innovative solutions for degenerative disc disease. Leveraging our expertise around naturally sourced treatment options, our team developed VIA Disc to maximize the regenerative powers of the body to provide patients with a minimally invasive option that provides lasting relief. The early evidence from the VAST study suggests VIA Disc is able to deliver meaningful and durable pain relief, restore function and improve quality of life. We look forward to continuing to build this important clinical body of evidence.”

The VAST Trial is a prospective, randomized, parallel-arm, multicenter study approved to enroll up to 220 subjects at up to 15 clinical sites. Outcomes of the trial were based on assessment of primary and secondary endpoints of six and 12 months after transplant of supplementary allograft compared with placebo or sustained conservative care in subjects who had discogenic pain attributable to disc degeneration as judged by magnetic resonance imaging scoring, physical examination and subject-reported pain.

About VIVEX Biologics, Inc.

VIVEX Biologics is a pioneer in regenerative medicine, specializing in the development of naturally sourced treatment options and solutions that improve clinical, surgical and therapeutic patient care through innovation. With tissue damage resulting from a variety of diseases, direct injury or trauma, there is a significant need for advanced solutions. By leveraging the resources of the nation’s oldest civilian tissue bank, VIVEX is channeling the body’s inherent healing qualities to bring patients optimal care and to provide medical professionals and patients with innovative treatment options for a broad range of indications.

ATLANTA and MIAMI, Feb. 12, 2020 /PRNewswire/ – VIVEX Biologics, Inc., a leading regenerative medicine company specializing in the development of naturally sourced, biologically engineered tissue products, today announced the appointment of Chad Kolean as chief financial officer.

“We are delighted to welcome Chad during this exciting time of growth at VIVEX,” said Peter Wehrly, chief executive officer of VIVEX. “Chad has an extensive track record of successfully leading operational, M&A and capital raising functions for a variety of companies within the life sciences space. We believe his skills and past experience are an ideal match for VIVEX as we endeavor to broaden our scope of delivering therapeutically viable restorative treatments to healthcare providers and their patients.”

“I am excited to be joining the VIVEX team,” said Mr. Kolean. “VIVEX’s world-class team has established an exceptional operation that is delivering transformative, restorative biologic options to patients in critical need of new and innovative solutions for a variety of conditions where tissue loss has occurred.”

Mr. Kolean brings to VIVEX substantial leadership experience in financial management for both private and public healthcare companies. Prior to joining VIVEX, Mr. Kolean served as CFO and treasurer for Titan Spine, Inc., a designer, manufacturer and distributor of surface-enhanced spinal implants, and was integral to the process that resulted in the acquisition of Titan by Medtronic.

Mr. Kolean previously served as CFO and treasurer for Cellectar Biosciences, Inc., a publicly traded, clinical stage, biopharmaceutical company developing compounds for the treatment, diagnosis and imaging of cancer.

Mr. Kolean also served as CFO and treasurer for Pioneer Surgical Technology, Inc., a $100M, global, design-driven manufacturer and distributor of spinal, biological and orthopedic implants, until the merger of Pioneer with RTI Surgical

Earlier in his career, Mr. Kolean held leadership positions of increasing responsibility for a number of other companies both within the healthcare space and beyond, including Tomotherapy, Inc., Metavante Corporation, Snap-On, Inc., Herman Miller, Inc., Kaydon Corporation and Arthur Andersen, LLP.

Mr. Kolean earned his Bachelor of Arts in Business Administration and Finance from Hope College and graduated Magna Cum Laude.

About VIVEX Biologics, Inc.

VIVEX Biologics is a pioneer in regenerative medicine, specializing in the development of naturally sourced treatment options and solutions that improve clinical, surgical and therapeutic patient care through innovation. With tissue damage resulting from a variety of diseases, direct injury or trauma, there is a significant need for advanced solutions. By leveraging the resources of the nation’s oldest civilian tissue bank, VIVEX is channeling the body’s inherent healing qualities to bring patients optimal care and to provide medical professionals and patients with innovative treatment options for a broad range of indications.

ATLANTA and MIAMI, Jan. 21, 2020 /PRNewswire/ – VIVEX Biologics, Inc., a leading regenerative medicine company specializing in the development of naturally sourced treatment options, today announced the company will host a panel discussion and luncheon at the Annual World Stem Cell Summit in Miami from January 21 – 24, 2020. During the panel discussion and luncheon, titled, “Exosome Identity and Evolving Clinical Utility,” esteemed physician-scientist panelists will discuss the diagnostic potential and clinical possibilities for exosome development.

Panel participants include: Kevin Hicok, Ph.D., Director of Research and Development for Direct Biologics, Inc.; H. Thomas Temple, M.D., Professor of Affiliated Orthopedics at Nova Southeastern University and Medical Director for VIVEX; Michael Donovan, M.D., Ph.D., Director of the Biorepository/Experimental Pathology program at Mount Sinai in New York City; and Timothy Ganey, Ph.D., Chief Technology Officer of VIVEX Biologics, who will moderate the Panel.

Additionally, Douglas Beall, M.D., Chief of Radiology Services at Clinical Radiology of Oklahoma in Oklahoma City and principal investigator of VIVEX’s VAST (Viable Allograft Supplemented Disc Regeneration in the Treatment of Patients With Low Back Pain) trial, will present an analysis of the 24-patient safety cohort from the study. This trial was the first to utilize supplemental allogeneic tissue to restore segmental biomechanics for patients who have experienced degeneration in the spine.

Details regarding the panel discussion luncheon and Dr. Beall’s presentation are as follows:

Title: Exosome Identity and Evolving Clinical Utility

Date: Wednesday, January 22, 2020

Time: 12:45 p.m. – 1:45 p.m. ET

Room: Hibiscus

Venue: Hyatt Regency, Miami

Title: Viable Allograft as a Supplement for Lumbar Intervertebral Disc Regeneration

Date: Wednesday, January 22, 2020

Time: 4:35 p.m. – 4:50 p.m. ET

Room: Orchid AB

Venue: Hyatt Regency, Miami

About VIVEX Biologics, Inc.

VIVEX Biologics is a pioneer in regenerative medicine, specializing in the development of naturally sourced treatment options and solutions that improve clinical, surgical and therapeutic patient care through innovation. With tissue damage resulting from a variety of diseases, direct injury or trauma, there is a significant need for advanced solutions. By leveraging the resources of the nation’s oldest civilian tissue bank, VIVEX is channeling the body’s inherent healing qualities to bring patients optimal care and to provide medical professionals and patients with innovative treatment options for a broad range of indications.

ATLANTA and MIAMI, Sept. 19, 2019 /PRNewswire/ — VIVEX Biologics, Inc., a leading Regenerative Medicine company, announced today that Peter Wehrly has been appointed the new CEO. Mr. Wehrly is a seasoned leader in the medical device and biotech industries that consistently delivers top-line growth and operational efficiencies.

Mr. Wehrly is the former CEO and serves as the current Chairman of the Board of Synaptive Medical, a privately held Toronto-based company that focuses on uniting highly innovative technology with the medical device industry for neuro-cranial and spinal markets. Wehrly served in several leadership positions at Covidien including Group President heading the global businesses in Western Europe, Japan, Canada, Australia and New Zealand. Prior to joining Covidien, he held various general management positions within Medtronic Inc., including Senior Vice-President Medtronic, President Spinal & Biologics and President of Medtronic Sofamor Danek. Additionally, Wehrly spent 17 years with DePuy Orthopedics, a Johnson & Johnson company where he served numerous roles of increasing responsibilities including VP of Sales & Marketing and President of DePuy OrthoTech.

“Today’s announcement underscores our commitment to finding a leader who can build on the Company’s current momentum and opportunities in the years ahead,” said VIVEX Biologics Chairman John McCallum. “After an extensive search, we have found that leader in Peter. His many years of experience and solid understanding of the medical device and bio-tech markets that VIVEX Biologics competes in, make him well qualified to lead the Company.”

“I am excited to join VIVEX Biologics,” said Peter Wehrly. “It is an honor to assume this leadership role, particularly at a time when the company is so well positioned to launch and develop new treatments to improve patient’s lives. I look forward to working with the great team at VIVEX Biologics as we continue to shape the company for the future.”

Wehrly has held numerous board positions at for profit and not-for-profit organizations. He earned his BS in Management from Ball State University and has completed several advanced management programs including a program at the IMD International School of Management in Lausanne, Switzerland.

About VIVEX Biologics, Inc.:

Guided by a commitment to improve therapeutic patient care through innovation, VIVEX strives to leverage new and existing technology platforms in order to develop novel approaches to regenerative treatment that improve people’s lives. Under the direction of experienced and successful business professionals, VIVEX engages the brightest minds from the medical and material science industries to explore new and different ways to help others. VIVEX works with organizations that are committed to providing care and compassion to donor families while inspiring communities to share life through their donations. Partnering with families in the prospect of regenerative options, VIVEX assures regeneration and translation of donor gifts.

Safe Harbor Statements: This press release contains forward-looking statements. These forward-looking statements are based on our current assumptions, expectations, and estimates of future events and trends. Forward-looking statements are only predictions and are subject to many risks, uncertainties, and other factors that may affect our businesses and operations and could cause actual results to differ materially from those predicted. These risks and uncertainties include, without limitation, factors affecting our financial results, demand for our products, our ability to obtain regulatory clearance or approval, where necessary, from the U.S. Food and Drug Administration, our ability to compete successfully, our ability to safeguard our intellectual property, and our ability to comply with laws and regulations that are or may become applicable to our businesses. Given these risks and uncertainties, readers are cautioned not to place undue reliance on any forward-looking statements.

SOURCE VIVEX Biologics, Inc.

MIAMI, June 6, 2019 /PRNewswire/ — Initial clinical results on VIA Disc, a non-surgical, minimally invasive procedure to repair, restore and supplement damaged discs resulting from degenerative disc disease (DDD) presented at the 47^thannual ISSLS (International Society for the Study of the Lumbar Spine) meeting in Kyoto, Japan.

Douglas P. Beall, MD, Chief of Radiology Services at Clinical Radiology of Oklahoma presented at the 47^th annual ISSLS (International Society for the Study of the Lumbar Spine) meeting in Kyoto, Japan on initial results from the VAST study, a prospective randomized multi-center study of 224 patients evaluating the safety and performance of VIA®Disc developed by VIVEX Biologics, a viable allograft delivered into a diseased disc. The procedure offers a novel approach to current options in the continuum of care for treating Chronic Lower Back Pain. It will be the first product on the market to treat the most common source of pain, the disc. “I am highly encouraged by the provisional results and safety data from the VAST study. Implantation of allograft can be done safely, and early evidence suggests improvement in VAS and ODI at 12 months. Interventions like VIA Disc have the potential for treating moderate degenerative discs and greatly advance the alternatives to surgical intervention,” said Douglas Beall, the Principal Investigator for the VAST study. The annual ISSLS meeting brings together individuals from throughout the world for the exchange of both clinical and investigative information related to low back pain and disability.

Atlanta, Ga., Miami, FL., October 16, 2018 — VIVEX Biologics, Inc., a leading Regenerative Medicine company, announced today that Lisa Colleran has been appointed the new CEO. Ms. Colleran is an experienced leader in the field of Regenerative Medicine and known in the industry for delivering strong business results and successfully creating shareholder value.

Former President, CEO and founder of VIVEX, Tracy Anderson will transition from the company’s CEO to take on the role of Vice Chairman. Anderson will remain on the VIVEX Board of Directors. “Tracy has done an incredible job as the founder and CEO of VIVEX, creating a leading tissue and cell therapy company with scientifically-based technologies, an unsurpassed patent portfolio and significant revenue in the spine and orthopaedic space.” says Bert Ellis, Chairman of the Board. “His leadership and innovative approach sets the company up for incredible success as we move into the next phase of growth.”

Ms. Colleran was the former CEO of LifeCell Corporation. During her 11-year tenure, LifeCell became one of the most successful medical device companies in plastic and general surgery. In the first 6 years of her tenure, LifeCell’s annual revenues grew from $25 million to approximately $200 million and its market valuation increased from $100 million to $1.7 billion, when LifeCell was sold in 2008 to a large medical device company. After the sale of the company, Lisa stayed on and lead the company through a second ownership transition, doubling the revenue to almost $400 million and creating significant shareholder value. Prior to joining LifeCell, Lisa spent 20 years at Baxter Healthcare in various commercial and general management roles.

“We are very excited about Lisa Colleran joining the VIVEX family as the company transitions to the next phase. She brings a wealth of experience that we believe will vault VIVEX to new levels of excellence. Although it has been my greatest honor running VIVEX since its inception, this change in leadership is a natural progression that will benefit all of our stakeholders,” said Tracy Anderson.

“I couldn’t be more thrilled to join VIVEX at this very exciting juncture in the company’s evolution. The team at VIVEX has built something unique, and I am honored to be a part of it. The current products have been proven to add clinical value to a wide variety of surgical procedures and the future products have the potential to completely change treatment paradigms, improving clinical outcomes for patients around the world”, stated Ms. Colleran.

About VIVEX Biologics, Inc.:

VIVEX is a regenerative biomedical company dedicated to creating new standards in patient care. VIVEX strives to create treatment options and solutions that will improve clinical, surgical, and therapeutic patient care through innovation. Under the guidance of experienced and successful business professionals, VIVEX engages the brightest minds from the medical and material science industries to explore new and different ways to help others. VIVEX works with services that are committed to providing care and compassion to donor families while inspiring communities to share life through their donations. Partnering with families in the prospect of regenerative options, VIVEX assures appropriate options are available to support regeneration and translation of their gifts.

Safe Harbor Statements: This press release contains forward-looking statements. These forward-looking statements are based on our current assumptions, expectations, and estimates of future events and trends. Forward-looking statements are only predictions and are subject to many risks, uncertainties, and other factors that may affect our businesses and operations and could cause actual results to differ materially from those predicted. These risks and uncertainties include, without limitation, factors affecting our financial results, demand for our products, our ability to obtain regulatory clearance or approval, where necessary, from the U.S. Food and Drug Administration, our ability to compete successfully, our ability to safeguard our intellectual property, and our ability to comply with laws and regulations that are or may become applicable to our businesses. Given these risks and uncertainties, readers are cautioned not to place undue reliance on any forward-looking statements.

For more information, please visit https://viadiscnp.com/ or contact info@vivex.com.

Atlanta, May 4, 2018 – VIVEX Biologics, Inc. (VIVEX) is pleased to announce the publication of a peer-reviewed study examining the use of its cellular bone matrix product, VIA Graft, for spinal fusion surgery. The peer-reviewed study was published in the January edition of the International Journal for Spine Surgery, and demonstrates exceptional clinical results.

The study represents a retrospective review of a single practice, single surgeon evaluation of VIA Graft. The study evaluated 75 consecutive patients for fusion by CT and radiographic evaluation at 12 months with a minimally invasive surgical approach. In total, 96% of the 75 patients with a total of 85 levels achieved fusion at 12 months – 96% of patients, 96.5% of levels treated.

“These clinical results with VIA Graft demonstrate VIVEX’s commitment to developing a disruptive product that will revolutionize the standard of care in orthopaedic surgery,” states Tracy Anderson, President & CEO of VIVEX.

The VIA product line was first launched in August of 2014 and has grown significantly with adoption across several orthopaedic surgical specialties. VIA Graft retains a biocompatible, mesenchymal stem cell-rich population that includes marrow-isolated adult multi-lineage inducible cells. The product also utilizes a proprietary non-DMSO cryoprotectant, affording optimal cell protection and streamlined preparation in the OR.

About VIVEX Biologics, Inc.:

VIVEX is a regenerative biologics company, dedicated to creating new standards in patient care. VIVEX strives to create treatment options and solutions that will improve clinical, surgical, and therapeutic patient care through innovation. Under the guidance of experienced and successful business professionals, VIVEX tasks the brightest minds from the medical and material science industries to explore new and different ways to help others. VIVEX focuses on core products and new technologies to meet the ever-growing biologic needs of surgeons and patients while continuing our 45-year history of serving and honoring both tissue donors and recipients.  As a part of this mission, VIVEX works with services that are committed to providing care and compassion to donor families while inspiring communities to share life through their donation. Partnering with families in the prospect of regenerative options, VIVEX assures appropriate options are available to support regeneration and translation of their gifts. VIVEX and its affiliates have distributed more than two million tissue allografts to 18 countries worldwide to better serve the needs of patients.

For more information, please visit https://viadiscnp.com/ or contact info@vivex.com.

MIAMI, FL – VIVEX Biologics, Inc. is proud to announce their platinum sponsorship of the 13^th World Stem Cell Summit (WSCS). The summit will take place January 22-26, 2018 at the Hyatt Regency Miami. “The 2018 World Stem Cell Summit is the global, super-ecosystem event, trans-disciplinary in scope,” explained Bernard Siegel, Founder of the WSCS and Executive Director of the RMF.

In addition to sponsoring WSCS, two of VIVEX’s most distinguished members will be presenting to fellow attendees and participants:

Advancing the exosome; extracellular vesicle into the mainstream

January 25, 11:30am – 1:15pm

H. Thomas Temple, MD; Chief Medical Officer

Tim Ganey, PhD; Chief Scientific Officer

President and CEO Tracy S. Anderson stated, “VIVEX is excited and honored to be part of such a prestigious and innovative event. We look forward to engaging with members of our field, working with other leaders in the industry, and discussing what is next for regenerative medicine.”

About VIVEX Biologics, Inc.

VIVEX Biologics, Inc. is a regenerative biologics company, dedicated to creating new standards in patient care. Since 2014, VIVEX and UMTB (founded 1970) have strived for methods to translate creative collaborations into treatments for real problems. In collaboration with multiple partners, VIVEX is on the cutting edge of scientific development. Translating innovation into treatments for real problems further expands surgical options. All research and development is focused on making strides in the field of musculoskeletal regenerative medicine, with major areas of investigation including: cartilage, bone, and skin. Innovative vision provides a platform that assists in the regeneration of all these tissue types in a personalized but scalable transplantation model.

About World Stem Cell Summit

Produced by Regenerative Medicine Foundation (RMF), this original, translation-focused, international and partnering conference is expecting 1,000 attendees from over 30 countries in the world, more than 210 participating organizations, and 100+ speakers.

For more information, please visit http://www.worldstemcellsummit.com/.