This week's life sciences industry news includes a medical technology company's new product launch, a biotech company's approval for its Pompe disease treatment, a Malvern antibiotics developer's progress with its experimental urinary tract infection therapy, and more.
Here's the roundup:
Tela Bio
The Malvern medical technology company launched a new product this week designed to expand reconstruction procedure options for surgeons and patients.
The new product, called the OviTex PRS Long-Term Resorbable, was developed for use in implantations for patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use.
Tela Bio (NASDAQ: TELA) CEO Antony Koblish called the Long-Term Resorbable an important addition to the company's OviTex PRS portfolio of reinforced tissue matrix products that have been used in more than 6,800 implantations at more than 400 health care centers.
"It will allow surgeons to address clinical indications that require longer term reinforcement while avoiding the use of permanent materials,” Koblish said.
Founded in 2016, Tela Bio's focus is on developing soft-tissue repair products that prioritize the preservation and restoration of the patient's own anatomy. Last week, the company reported its second quarter financial results that showed for the first half of 2023 it generated revenue of $26.4 million and a net loss of $22.8 million. Last year, Tela Bio posted sales of $41.4 million and a net loss of $44.3 million. The company has 123 employees.
Amicus Therapeutics
The Philadelphia biotechnology company's two-component Pompe disease treatment Pombiliti and Opfolda was granted marketing authorization from the Medicines and Healthcare Products Regulatory Agency (MHRA) of the United Kingdom.
Pompe disease is a rare, debilitating and life-threatening lysosomal disorder caused by a deficiency of the enzyme acid alpha-glucosidase. Late-onset Pompe is characterized by progressive muscle weakness throughout the body that worsens over time, particularly skeletal muscles and muscles controlling breathing.
“The MHRA approvals for Pombiliti and Opfolda are a major step forward for adults in the U.K. living with late-onset Pompe who are seeking new treatments," said Bradley Campbell, CEO of Amicus (NASDAQ: FOLD).
Pombiliti is a long-term enzyme replacement therapy used in combination with miglustat, a Gaucher disease drug, for adults with late-onset Pompe disease. Opfolda is an enzyme stabilizer for adults with the condition.
Venatorx Pharmaceuticals
The Malvern pharmaceutical company's new drug application for cefepime-taniborbactam, its experimental treatment for adults with complicated urinary tract infections, was accepted for review by the Food and Drug Administration.
The federal agency is scheduled to rule on the application by Feb. 22, 2024.
The FDA previously granted qualified infectious disease product and fast track designations to cefepime-taniborbactam. Those designations provide the company with benefits that include priority review.
Christopher Burns, CEO of Venatorx, said the government's acceptance of the company's application was the result of the collaborative efforts of the company's staff, its partners and the clinical investigators for its studies.
"By addressing the evolving and increasing challenges posed by antimicrobial resistance, we aim to make a meaningful impact on global public health," Burns said.
Quick Hits
Exton-based Frontage Laboratories Inc. and its wholly-owned subsidiary, Frontage Canada Inc., completed the acquisition of Nucro-Technics Inc. and its affiliate Nucro-Technics Holdings. Terms of the deal were not disclosed. Nucro-Technics is a Canadian pharmaceutical contract research organization that conducts analytical chemistry, microbiology, toxicology, bioanalytical, and stability sample storage and testing services along with consulting services. Briacell (NASDAQ: BCTX), a biotechnology company with offices in Philadelphia and Vancouver, was awarded a $399,918 research grant from the National Cancer Institute. The company plans to use the funds to advance its personalized off-the-shelf immunotherapies for cancer. … Helius Medical Technologies (NASDAQ:HSDT), a Newtown-based neurotech products company, implemented a 1-for-50 reverse split of its class A common stock.
