Device for Surgical Adhesion Prevention

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$266,001.00
Award Year:
2010
Program:
SBIR
Phase:
Phase I
Contract:
1R43GM090341-01A1
Agency Tracking Number:
GM090341
Solicitation Year:
2010
Solicitation Topic Code:
NIGMS
Solicitation Number:
PHS2010-2
Small Business Information
NOVELMED THERAPEUTICS, INC.
NOVELMED THERAPEUTICS, INC., 2265 ENTERPRISE PKWY, TWINSBURG, OH, 44087
Hubzone Owned:
N
Socially and Economically Disadvantaged:
N
Woman Owned:
Y
Duns:
190155171
Principal Investigator:
REKHA BANSAL
(440) 477-9874
REKHA@NOVELMED.COM
Business Contact:
REKHA BANSAL
(440) 477-9874
rekha@novelmed.com
Research Institution:
n/a
Abstract
DESCRIPTION (provided by applicant): Postoperative adhesion formation is the single greatest complication of surgery. Twenty seven million surgical procedures are performed annually in the U.S. where the patient is at risk for the complications from surgical adhesions. After surgery, fibrous adhesions form in the peritoneum, central nervous system, pericardium, pleura and synovium. Fibrous adhesion that develop after surgery cause complications that markedly increase healthcare costs due to increased rates of re-operation, postoperative bowel obstruction, infertility, and chronic pain. Despite the need for anti-adhesive treatments, there are currently no FDA approved prevention devices that effectively prevent surgical adhesions following spinal and laparoscopic surgery. One obstacle to gaining FDA approval for therapies targeting prevention of adhesions has been the lack of good clinical endpoint measures to assess treatment efficacy. NovelMed has developed a novel synthetic carbohydrate, NM2040, based on a previous synthetic anionic carbohydrate, ADCON, which despite successfully inhibiting adhesions, and had reports of significant side-effects. NovelMed recently discovered that ADCON is toxic to platelets. Given the critical role of platelets in hemostasis and wound healing, ADCON's side-effects could be linked to platelet toxicity. NM2040 was developed to overcome the toxic effects of ADCON on platelets. Preliminary findings indicate that this biocompatible conjugate can effectively inhibit surgical adhesions by preventing invasion and proliferation of cells associated with fibrosis development into the surgical site without platelet toxicity. The objectives of this application are 1) to test the feasibility of using NM2040 as a treatment to prevent surgical adhesions using a validated lumbar spine laminectomy model; 2) to develop a surgical adhesion model for gynecological adhesions for which good clinical endpoint measures are available; and to determine efficacy of NM2040 to prevent fallopian tube adhesions. Our ultimate goal is to develop an effective FDA approved anti-adhesion device for use in back and abdominal surgeries. PUBLIC HEALTH RELEVANCE: Postoperative adhesion formation is the single greatest complication of surgery. Twenty seven million surgical procedures are performed annually in the U.S. where the patient is at risk for complications that markedly increase healthcare costs due to increased rates of re-operation, postoperative bowel obstruction, infertility, and chronic pain. The objectives of this application are 1) to test the feasibility of using NM2040 as a treatment to prevent surgical adhesions using a validated lumbar spine laminectomy model; 2) to develop a surgical adhesion model for gynecological adhesions for which good clinical endpoint measures are available; and to determine efficacy of NM2040 to prevent fallopian tube adhesions. Our ultimate goal is to develop an effective FDA approved anti-adhesion device for use in back and abdominal surgeries.

* information listed above is at the time of submission.

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