Patrick Balsmann Email & Phone Number

Effingham, Il, Us

Bonutti Technologies is FDA registered and I have been responsible for multiple FDA 510(k)s including orthopedic sports medicine implants (e.g., suture anchors & trauma fixation devices). Products included the first allograft suture anchor cleared by the FDA and tissue fixation biodegradable implant devices involving our novel ultrasonic technology. Recent development projects have included FDA 510(k) clearance for our JAS Pulse Ultrasonic Therapy Device. The JAS Pulse is an ultrasound diathermy device that will be distributed by Joint Active Systems (JAS). I am responsible for all RA/QA & Clinical development for JAS including FDA and international registrations.AxioSonic has just completed a clinical trial and a Pre-Submission meeting with FDA.

I have coordinated development of the clinical trial for our AxioSonic ultrasonic device used to treat chronic sinusitis. This has included writing of the protocol & developing case report forms, presentations to the IRB, and the monitoring of the study with the principal investigator.

Greater St. Louis Area

Storz Instrument is a leading ophthalmic medical device company that is now part of Bausch & Lomb. While at Storz I ventured out of the cell biology lab and became involved in clinical research and regulatory affairs. This included:- Prepared 510(k)s for phacoemulsification ultrasound systems & disposable accessories- Coordinated cross-functional FDA pre-submission meeting at FDA for novel glaucoma device. - Managed clinical investigator meeting of 15 cataract surgeons for intraocular lens (IOL) IDE.- Prepared & managed IDE cochlear implant close-out including patient follow-up & termination offer.- Prepared IDE/PMA sections related to clinical trials for PMA submissions- Supervised cell biology lab including personnel & development of histology & biochemical techniques.

Greater St. Louis Area

Invitron Corporation was a biotech pharmaceutical company using proprietary continuous flow bioreactor technology to manufacture cell-secreted proteins. While at Invitron I:- Designed & performed cell biology experiments involving genetically engineered cell lines for potential therapeutics.- Developed & performed metabolic biochemical testing including HPLC and ELISA techniques.

Master Of Business Administration (Mba)

Master Of Science (Ms), Cell/Cellular And Molecular Biology

Bachelor Of Science (B.S.), Zoology/Animal Biology

Education record

Education record