Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


In Brief: Biomatrix

This article was originally published in The Gray Sheet

Executive Summary

Biomatrix: Patient enrollment is under way for multi-center U.S. clinicals of Hylagel Uro following FDA approval of an investigational device exemption. Designed to treat urinary incontinence, the viscoelastic gel device is "injected intramuscularly to augment the soft connective tissue between the sphincter and the muscles of the urethra". Biomatrix anticipates its hylan B-based product will compete directly with Collagen's Contigen, a collagen-based urinary incontinence treatment approved in 1993 ("The Gray Sheet" Oct. 4, 1993, p. 1). Biomatrix expects to meet with FDA soon to discuss resubmission of its premarket approval application for its Hylaform viscoelastic gel for use in removing depressed scars and facial wrinkles, which was recently withdrawn. "The Gray Sheet" (Jan. 5, In Brief) incorrectly reported that the company would discuss with FDA the need for additional skin test data on allergic reactions and labeling changes. Biomatrix says there have been no reports of allergic reactions to Hylaform...

You may also be interested in...

Corindus Envisions Network Of CorPath Robots For Remote Neurovascular And Coronary Interventions

The physician who led the first first-in-human robotic-assisted neurovascular intervention with Corindus’ CorPath GRX system believes the technology could revolutionize neurovascular intervention by allowing a centralized interventional team to remotely treat patients.

MTI Top 100: Leading Medtechs See Steady Organic Growth In A Market On The Cusp Of Change

The disruptive medtech M&A of recent years was not matched in the past year for volume, but there were isolated outbreaks of major activity, as shown in our company rankings. 

Hikma And Civica Ship Eight Essential Injectables

Hikma and Civica Rx have announced the launch of a first wave of eight essential injectable medicines, including heparin, as part of a deal struck between the two firms earlier this year.




Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts