Full start-up news profile reprinted from Medtech Insight - August 2008
More than a million suspicious breast lumps are detected each year in women in the US, and that contributes to the performance of more than 650,000 lumpectomies annually to remove tumors. Although the procedure is an effective way to deal patients have been seeking a less invasive treatment that would deliver the same positive results. Find out about an alternative that may be ready with technology developed by a privately held company based in Chicago.
Full start-up news profile reprinted from Medtech Insight - August 2008
More than a million suspicious breast lumps are detected each year in women in the US, and that contributes to the performance of more than 650,000 lumpectomies annually to remove tumors. Although the procedure is an effective way to deal with potentially cancerous growths in their early stages, physicians and patients have been seeking a less invasive treatment that would deliver the same positive results. That alternative may be ready with technology developed by a privately held company based in Chicago.
Novian Health Inc. has developed a minimally invasive device and surgical process that destroys tumors with heat delivered via laser energy from an optic fiber that is threaded through a small needle and inserted into the tumor. The Novilase Breast ILT (Interstitial Laser Therapy) System has already received FDA 510(k) approval to be used in the treatment of benign breast tumors up to 2 cm. The company is working to expand the list of indications and is the process of planning clinical trails to study the treatment of malignant tumors.
This minimally invasive alternative offers a number of benefits over a lumpectomy, including minimal scarring and faster recovery times. Additionally, the company-developed procedure can be performed on an outpatient basis in about 30 minutes and only requires a local anesthetic, all of which greatly reduce costs to the patient and the provider.
Novian hopes to commercialize its technology by working with breast centers and company-operated sties. Officials optimistically believe that once payor reimbursement is established for the procedure, a single site could be profitable performing at least 12 procedures a month.
The company is looking for investors as it seeks to capitalize on the success it has had to date, which not only includes its first FDA clearance, but also testing that has shown the Novilase Breast ILT method is faster and less traumatic than invasive breast surgery. In the testing, 70 procedures were performed on 64 patients, and no significant adverse events were reported.
Novian also has begun initiating commercial operations and has established a training site at Rush University Medical Center, where one of the cofounders of the company is a professor of surgery.
Start-Up News is regular feature in Medtech Insight. Other start-ups featured in this month's issue:
Noteworthy news from medtech start-ups, including Vasorum's redefinition of vascular closure, Novian Health's energy-based breast tumor ablation, Tissue Genetics' molecular diagnostics for cancer, and Aponos Medical's wound closure for NOTES.
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