Company
Portfolio Data
Back to Company Search21MEDTECH LLC
Address
21 PARMER WAYDURHAM, NC,
USA
UEI: ZN79YPX5YL63
Number of Employees: 5
HUBZone Owned: No
Woman Owned: Yes
Socially and Economically Disadvantaged: No
SBIR/STTR Involvement
Year of first award: 2021
0
Phase I Awards
2
Phase II Awards
N/A
Conversion Rate
$0
Phase I Dollars
$3,723,209
Phase II Dollars
$3,723,209
Total Awarded
Awards
ARRAY: A novel polymeric mesh for prophylactic antibiotic protection of cardiac implantable electronic devices
Amount: $1,992,458 Topic: NHLBI
PROJECT SUMMARY 21MedTech, LLC is developing the ARRAYTM antibiotic-loaded envelope to address the need for novel methods to tackle rising rates of infections associated with cardiovascular implantable electronic devices (CIEDs). There were 1.5 million CIEDs implanted in 2011 and that number continues to grow. Between 1% and 4% of implantations result in infection, which have potential for severe morbidity and mortality outcomes. The mortality rate from CIED associated pocket infections can be as high as 66% if the device is not removed and up to 18% with device removal and antibiotic therapy. To address the need for additional methods to reduce or prevent these infections, 21MedTech is developing the ARRAY envelope for longer-term protection. The ARRAY envelope employs a novel bioresorbable polymer film that facilitates the controlled release of rifampin and minocycline locally following surgical implantation of a CIED. The envelope is highly tunable, enabling control over drug release and degradation time, and has been shown to be highly biocompatible in vivo. Prior to this Direct to Phase II proposal, 21MedTech has demonstrated safety and efficacy of the envelope material in vitro and in vivo and has demonstrated feasibility with controlled release of rifampin and minocycline over 28 days. 21MedTech has also shown improved drug release profiles over the commercially available TYRXTM envelope in vitro, which exhibits a burst release (>90%) in the first 24 hours. The goals of this proposal will be to optimize release of antibiotics from the envelope, assess safety and efficacy, and to determine the effective dose in a well-defined animal model. Success with these goals will advance the ARRAY envelope towards FDA clearance. Commercialization of the ARRAY envelope will improve CIED surgical outcomes and improve patient quality of life by reducing CIED associated infections.
Tagged as:
SBIR
Phase II
2023
HHS
NIH
Non-Opioid Post-Operative Pain Management Using Bupivacaine-loaded Poly(ester urea) Mesh
Amount: $1,730,751 Topic: 300
SUMMARY 21MedTech, LLC is developing SERENZATM, a non-opioid analgesic that is released from a bioresorbable film for post-surgical pain management. Post-surgical pain management is a significant contributor to the risk for opioid addiction and diversion. There were nearly 129 million outpatient surgeries in the U.S. in 2018 and orthopedic surgeons alone account for nearly 8% of all opioid prescriptions in the U.S. Though the risk for addiction and diversion is high, there are currently few alternative options to opioids for the management of post- surgical pain and new approaches are needed to reduce patient exposure to these drugs and improve the ongoing opioid crisis. There have been several products and therapies attempting to provide non-opioid postoperative pain relief, but these products only work for 24 to 48 hours, despite claims otherwise, and others still require additional rescue medication. To meet this urgent need, we are developing SERENZA. SERENZA is a polymer film loaded with local anesthetic that is implanted at the surgical site following operation. Tunable formulation of the film and loading enable control over local release for pain relief for up to four days following surgery. The polymer film is bioresorbable and safely degrades over time. We have demonstrated safety of our polymer film carrier, efficacy of the drug, and proof-of-concept of our system in vivo. Our Phase II objectives are to optimize drug release kinetics and develop manufacturing standards, determine effective dosage for retention of motor function, and determine safety and efficacy in mouse neuropathic pain models. Completion of these goals will progress SERENZA toward first in-human clinical trials and successful FDA approval. Successful approval and commercialization of SERENZA will enable a powerful new strategy for providers to reduce or potentially eliminate the use of opioids and the risk of opioid use disorder for patients following surgery.PROJECT NARRATIVE There is an urgent need to develop non-opioid postoperative pain management solutions. In this project, we are developing a bioresorbable drug delivery product that can release controlled amounts of non-opioid analgesic over time to manage pain for several days following surgery. Continued development and successful FDA approval of this product will reduce or eliminate the need for opioids postoperatively. This will significantly reduce patient exposure to these drugs and stem the ongoing opioid crisis while providing safe and effective pain relief.
Tagged as:
SBIR
Phase II
2021
HHS
NIH