Admedus has sold its CardioCel and VascuCel patch business to US-based LeMaitre Vascular for up to $A36.2M ($A22.8M upfront) in cash payments. A press release reports that these products originated from the Admedus’s proprietary, regenerative bioscaffold platform technology and are used to address multiple cardiovascular procedures and repairs. The company’s CEO, Wayne Paterson, says that the transaction will enable them to explore advancing its transcatheter aortic valve implantation (TAVI) programme and other potential products

According to a press release, the CardioCel product range is the only one to have achieved 10 years without calcification or degradation in humans—a significant benefit to patients otherwise forced to undergo recurrent operations. The press release reports that surgeons use CardioCel products to treat congenital heart defects, vessel and cardiovascular repairs, and peripheral vascular reconstruction. VascuCel is used as a patch in great vessel repair, peripheral vascular reconstruction and suture line buttressing. 

Under the agreement terms, Admedus receives $A22.8M upfront followed by deferred payments of $A1M each at 12 months and at 36 months. Additionally, it may receive up to $A11.4M in earn-out payments as follows:

  • $A3.0M on obtaining certain regulatory approvals under European Medical Devices Directorate Regulation.
  • $A0.7M on Admedus completing all testing and documentation to extend the shelf life of the CardioCel and VascuCel products from 36 months to at least 60 months in the USA.
  • Up to $A3.73M if gross revenue from LeMaitre CardioCel and VascuCel product sales exceed $A29.8M in the first 12 months or $A1.8M if gross revenue from product sales exceed $A22.4M in the first 12 months
  • Up to $A3.73M if gross revenue from LeMaitre CardioCel and VascuCel product sales exceed $A44.7M in the second 12 months or $A1.8M if gross revenue from product sales exceed $A33.5M in the second 12 months.
  • $A0.2m for completion of reporting procedures by 31 October 2019

(All amounts at the current $US0.67/$A1 rate.)

Admedus retains manufacturing rights for up to three years and will continue manufacturing CardioCel and VascuCel at its Malaga facility in Western Australia for LeMaitre. The manufacturing agreement ensures Admedus a 20% margin over cost. Furthermore, Admedus retains sole-control on all intellectual property for the underlying Adapt technology platform/process, including its breakthrough TAVI device and single-piece 3D aortic valve.

Patterson comments: “This transaction is a transformational milestone for Admedus, realising the value from its CardioCel and VascuCel products. Importantly, the deal firmly positions the Company for its next growth phase anchored by its ground-breaking TAVI programme.”

He added that the company plans its first-in-human studies for its single-piece 3D aortic valve in 2020. “Based on Admedus’ current laboratory and animal study findings—combined with the highly differentiated anti-calcification properties of all products generated using the ADAPT technology—there is potential for single-piece 3D aortic valve and TAVI devices to be breakthrough for patients,” Patterson explained.

The press release reports that LeMaitre is a global provider of implants and devices for the treatment of peripheral vascular diseases.