OUR VISION

Working in partnership with surgeons, we create, develop, and distribute innovative surgical products. At Biom’up, we are dedicated to optimizing surgery with a double objective: to boost surgeons performances and improve patients well-being.

OUR KNOW-HOW

Founded in 2005, Biom’up, a specialist in collagen-based absorbable medical devices for biosurgery, is developing a new generation hemostatic product composed of patent-protected biopolymers. With broad expertise in biomaterials, Biom’up is creating innovative and clinically proven products that are used in many surgical specialties such as cardiothoracic and general surgery. Biom’up is committed to the design, development, and delivery of novel, high-performing solutions that make life easier for surgeons and better for patients.

OUR TEAM

MEDICAL AFFAIRS

 

WILLIAM D. SPOTNITZ, M.D., M.B.A.

Chief Medical Officer
Dr. Spotnitz is an international expert in the field of hemostats, sealants, and adhesives with more than 70 publications in this area. He has extensive experience in surgical needs assessment, device design, preclinical experimentation, clinical trials, FDA regulatory affairs, product education, and marketing to health professionals having collaborated with more than 30 different companies in these areas.

 

REGULATORY AFFAIRS

 

TOM MAGUIRE, M.B.A.

Vice President Regulatory Affairs & Chief Compliance Officer US
Tom has been leading regulatory, clinical, quality and compliance teams for more than 20 years (Synthes, EPMedsystems, Kensey-Nash, DSM Biomedical). Tom has been responsible for worldwide regulatory and clinical strategy for a range of regenerative implant products used in orthopedic, spine, general surgery, plastic & reconstructive, cardiovascular and dental procedures. He has also directed product development activities specific to anti-microbial enhancements for devices. Tom has a B. Sc. in Physics and an MBA in International Business.

 

CLINICAL AFFAIRS

 

RACHEL HOFFMAN

VP Clinical Operations North America
Rachel Hoffman has joined the Biom’up as our VP Clinical Operations of North America. She will be responsible for providing leadership and support to all aspects of clinic operations for the USA. Rachel is a versatile biomedical engineer and medical device expert who combines research background, regulatory expertise, clinical operations, and program strategy skills. Rachel has an extensive experience in medical device and clinical operations with leading companies including NAMSA and CryoLife, Inc.. She has a BSE in Biomedical Engineering from Duke University of Engineering.

 

MARKETING

 

STEVEN FORD

Vice President of Marketing US
Mr. Ford has worked for nearly 18 years in the field of medical devices, in product management and marketing functions (CR Bard Inc, Ethicon Inc., Allergan Inc., etc.). In the hemostasis segment, he worked for more than six years at Baxter (BioScience and BioSurgery divisions), and most recently exercised the position of director of marketing (BioSurgery) at Mallinckrodt Pharmaceuticals.

PAUL URICCHIO

US Marketing Director
Paul Uricchio who has joined the Biom’up Commercial Team as our US Director of Marketing. Paul will be leading key launch activities/projects to help ensure a successful launch of HEMOBLAST™ Bellows in the US. Paul comes to us with a highly successful track record within the Biosurgical/Biopharma industry from companies such as Mallinckrodt, The Medicines Company and ZymoGenetics.  Paul has extensive surgical device experience which includes significant time launching products within the hemostasis market. Paul earned his MBA in Healthcare and Pharmaceutical Marketing from St. Joseph’s University and his BA in Speech Communications from Lock Haven University.

 

SALES

 

DAVE CLARK

Vice President of Sales US
Dave has extensive commercial experience which includes 25 years in the surgical device industry with leading companies including Medtronic and Baxter Healthcare. He has very strong domain experience within the hemostasis market from his 15 years with Baxter BioSurgery where he performed numerous commercial roles including senior level sales leadership. During his time with Baxter, the BioSurgery Division grew from a small revenue business into a major market player in the advanced hemostasis space with products such as FloSeal and Tisseel. Dave has a B.A. in Economics from Rutgers University.

CLAY BEATY

Area VP Sales Western US
Clay Beaty who has joined the Biom’up Commercial Team as our Area Vice President Sales – Western U.S.  Clay will be leading, developing and managing our Western U.S. Sales Team and Sales Management Team. Clay has over two decades of surgical device experience including significant time in sales and sales management within the hemostasis market within companies such as St Jude Medical and Baxter. In addition, he has extensive experience in senior sales leadership roles. Clay earned his B.S. Organizational Communications from Missouri State University.

KEN MINGUS

Regional Business Director
Ken Mingus who has joined the Biom’up Commercial Team as our Regional Business Director- West Coast.  Ken will be leading and managing our West Coast Sales Team from his location in Los Angeles. He comes to us with a highly successful track record within the surgical device industry from companies such as Mallinckrodt, Baxter and Genzyme.  Ken has extensive surgical device experience which includes significant time driving revenue growth within the hemostasis market. In addition, he has broad commercial experience with surgical devices used by a variety of surgical specialties and in particular, cardiac surgery.  Ken earned his B.S. Business Management from the University of Phoenix.

2005

Creation of 

2006

ISO 9001 and ISO 13485 certifications

2007

Approval and development of the first OEM products

2008

Raised 1,5 M€

2010

Raised 3 millions of euros

2015
  • Biom’up announces authorization by the  to start the IDE clinical pilot study of HEMOBLAST™ Bellows
  • The launch of this trial confirms the hemostasis expertise of Biom’up
2016
  • CE marking of HEMOBLAST™ Bellows
  • Completion of IDE pilot study (n=27)
  • FDA approves the IDE for the start of the pivotal clinical study for HEMOBLAST™ Bellows
  • Began IDE pivotal study – controlled, prospective, randomized, multicenter trial, assessing the efficacy and safety of HEMOBLAST™ Bellows in cardiothoracic, abdominal, and orthopedic lower extremity surgeries
  • Completion of enrollment for interim analysis.
2017
  • Completion of the pivotal clinical study assessing HEMOBLAST™ Bellows
  • Biom’up receives FDA marketing approval for HEMOBLAST™ Bellows
  • Biom’up launches its IPO on the Euronext regulated market and raise 38,1 M€
  • European pre-launch
2018

Opening of the Biomu’up Corporate office in Manhattan, NYC

Caution: Federal law restricts this device to sale on or by the order of a physician. The trademark of HEMOBLAST™ Bellows and SPOT GRADE™ are the property of Biom’up. The trademarks of the products listed herein are trademarks of their respective manufacturer. Please refer to the Instructions for Use accompanying each device for further information. The presentation contains pictures owned by third party and remains their property.
E-MR-318-V1
HEMOBLAST™ Bellows Hemostatic Agent [instructions for use: E-MR-217-V6]