News February 2022

TissueTech/Amniox Medical to Rebrand as BioTissue

TissueTech, Inc., Amniox Medical and Bio-Tissue, Inc. will now be known under a single corporate entity: BioTissue, Inc.

By adopting the BioTissue name across the entire organization, TissueTech will also reflect that innovative heritage and promise in its surgical business, which was previously known as Amniox Medical, according to a press release.

BioTissue’s innovative amniotic membrane products will retain their trusted brand names, including Prokera^®, AmnioGraft^®, AmnioGuard^®, Neox^®, and Clarix^®. All these products use the company’s proprietary CryoTek^® cryopreservation technology, designed to retain the tissue’s structural and functional integrity.

Since its inception in 1997, BioTissue notes it has pioneered the clinical application of human placental tissues. While most companies in the regenerative medicine space utilize only amniotic membrane tissue, BioTissue offers products leveraging the unmatched power of tissue derived from the umbilical cord—providing a thicker graft and delivering more regenerative biology, according to a press release.

Today, more than 680,000 patients have been treated with BioTissue’s products and its scientific and clinical advancements have been documented in over 380 peer-reviewed publications. BioTissue says it continues to break new ground with multiple investigational new drug clinical trials underway to secure biologics license applications for indications to address unmet clinical needs in the ocular, orthopedics, and wound management markets.

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Lympha Press Announces New Chief Medical Officer

Lympha Press, which develops pneumatic compression therapy for treatment of lymphedema and chronic venous disease, has announced the appointment of Karen Herbst, MD, PhD, as Chief Medical Officer.

“Dr. Herbst’s vision, leadership, and standard of excellence are well known in the clinical communities we serve,” remarked Eric Ansart, Lympha Press president in a press release. “We share the same goal: to provide the best possible care for patients who suffer from lymphedema, lipedema and venous disease. With the appointment of Dr. Herbst, we aim to elevate not only our understanding of these conditions, but also to develop heightened awareness of leading-edge best practices to manage them.”

“In today’s busy world, optimizing the use of at-home intermittent pneumatic compression (IPC) therapy is key for patients with lipedema, lymphedema and vein disease,” noted Dr. Herbst in a press release. “The science shows us that connective tissue will become increasingly important in the description of all diseases, and IPC has been shown to improve quality of life scores by reducing edema and the discomfort associated with these conditions.”

“Earlier treatment—not waiting until people are suffering and have lost their jobs or their friends and family because they are unable to function as they had previously is my hope for the future,” said Herbst. “Lympha Press embodies this patient-first perspective, which adds to my excitement about working with such a dedicated team of professionals.”

Dr. Herbst has held faculty positions at Martin Luther King Drew Medical Center/UCLA, the VA San Diego Health Care System/UCSD, and the University of Arizona. She won the Lifetime Achievement Award from Tucson Business in 2019 and was named one of America’s top physicians. Since 2000, her work has focused on those with fat (connective tissue) disease. In 2019, Dr. Herbst headed up a National Institutes of Health–sponsored conference to establish the standard of care for lipedema and in 2020 she presented new ICD-10 codes for lipedema and Dercum's disease to the CDC. 

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Merakris Therapeutics Teams Up With VA to Test Wound Healing Therapy

Merakris Therapeutics has entered into a Cooperative Research and Development Agreement (CRADA) with the United States Department of Veterans Affairs (VA) to test its investigational therapy, Dermacyte Amniotic Wound Care Liquid.

The VA plans to enroll several dozen patients, ages 18–75, in a two-part Phase 2 clinical study to evaluate Merakris’ first-in-class subcutaneous injectable wound healing product, notes the company. The study will determine the frequency of administration, safety and effectiveness of Dermacyte Liquid in treating non-healing venous stasis ulcers. These types of ulcers are caused by problems with blood flow in the veins of the legs.

Merakris notes Dermacyte Liquid is a sterile-filtered injectable solution made from human amniotic tissue and fluid. The product works by stimulating the migration of skin cells and triggering gene expression pathways to help wounds heal faster.

If approved, Dermacyte Liquid will be the first subcutaneous biologic to treat venous stasis ulcers, according to the company. Merakris said prescreening will begin soon for patients with non-infected venous stasis ulcers who have not improved after at least four weeks of conventional wound therapy. Merakris says the clinical trial should begin within the next several weeks.

Participants will be randomized 1:1 to receive Dermacyte Liquid either weekly or biweekly in the first part of the 12-week study, and the company says the data will be used to determine the best dosing frequency for the double-blinded and placebo controlled second part of the study. Reductions in participants’ wound surface area will be measured against baseline in weeks four, eight and 12. Total wound closure also will be evaluated at the end of week 12.

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