AVITA Medical Announces Institutional Placement of A$16 Million to Support U.S. Commercialization of the RECELL Device

mJOULE Launches in the United Kingdom Reports Sciton

"Sciton is dedicated to worldwide support and growth. We continue to demonstrate our commitment to developing high quality devices and marketing efforts for our physician and medspa partners worldwide." says Lacee J. Naik, Vice President of Marketing and Public Relations.

FDA Issues Draft Guidance on Remanufacturing and Discussion Paper Seeking Feedback on Cybersecurity Servicing of Medical Devices

With this in mind, the FDA is issuing today's draft guidance to help clarify whether activities performed on medical devices are likely remanufacturing as well as a discussion paper on cybersecurity servicing of devices.

Irrimax Receives FDA Clearance for Irrisept

"This new clearance from the FDA further solidifies Irrisept as the market leader in wound irrigation," said Mark Alvarez, CEO of Irrimax.

June 6, 2018

AVITA Medical, a regenerative medicine company with a technology platform positioned to address unmet medical needs in burns, chronic wounds, and aesthetics indications, today announced an institutional placement of A$16 million to prepare for the planned U.S. launch of the RECELL Device in the treatment of severe burns.

Avita Medical has received commitments from institutional investors for placement of A$16 million at an issue price of A$0.050 per share, with the placement to occur in two tranches. Tranche 1 of the institutional placement, totaling A$12.77 million, is expected to settle on 12 June 2018. Closing of Tranche 2 totaling A$3.25 million is subject to shareholder approval at an Extraordinary General Meeting to be held in July 2018.

“We appreciate the support of our shareholder group and the investors in this institutional placement as we proceed toward a transformative series of events for AVITA Medical, including the U.S. market launch of the RECELL Device,“ said Dr. Michael Perry, Chief Executive Officer. “Proceeds from this placement will ensure that we are positioned to take full advantage of the expected upcoming PMA approval of the RECELL Device in the U.S., including the establishment of our marketing and sales team, scale-up of manufacturing capabilities and expansion of clinical development. The extensive series of clinical data presented at the recent ABA and ISPOR conferences strongly supports the value of RECELL in the treatment of severe burns, and we have an exceptional commercial opportunity resulting from the unique combination of improved patient outcomes and substantial health economic benefits.”

The RECELL Device is an investigational medical device in the U.S. that is designed to enable medical professionals to produce, at the point-of-care, a REGENERATIVE EPIDERMAL SUSPENSION™ (RES™) using a small sample of the patient’s own skin. The autologous suspension contains cells necessary to regenerate epidermis and provides a new way to achieve permanent closure in burns and other wounds while reducing the amount of skin harvested at the time of surgery. Reduction in donor-site skin requirements has important benefits from both clinical and health economic perspectives.

A U.S. PreMarket Approval (PMA) application for the treatment of burn injuries is currently under review by the U.S. Food and Drug Administration (FDA). Avita Medical expects completion of the FDA review of the PMA during the third quarter of calendar 2018, followed by U.S. approval and market launch.  In April 2018 researchers from major burn centers throughout the U.S. made six presentations at the American Burn Association (ABA) 50th Annual Meeting in Chicago describing the clinical and cost-savings advantages of the RECELL Device in the treatment of severe burns.

Institutional Placement

The institutional placement was managed by Bell Potter as sole lead manager, and has been oversubscribed as the Company has received commitments for A$16 million at an issue price of A$0.050 per fully paid ordinary share.  Upon completion of the placement, the Company will issue up to 320,475,665 shares to international and Australian institutional and sophisticated investors to whom disclosure was not required pursuant to Chapter 6D of the Corporations Act 2001. The issue price of $0.050 per share represents a 3.8 percent discount to the last closing price on 1 June 2018, and a 6.3 percent discount to the 30-day VWAP of the Avita share price prior to the Company seeking a trading halt. The new Avita shares to be issued under the institutional placement will rank equally with existing Avita shares on issue.

“We are pleased to move toward the completion of this institutional placement to ensure that resources are in hand to strengthen our position and ensure that we are fully enabled to take advantage of opportunities facing us, including the upcoming U.S. launch of the RECELL Device,” said Dale Sander, Avita Medical Chief Financial Officer.  “We note that the issue price of this institutional placement is higher than that of our last financing round, and is within the range at which our shares have traded for the past 30 days.”

Tranche 1 of the institutional placement totals A$12,773,783 of proceeds and the issuance of 255,475,665 shares.  For Tranche 1 the Company will issue 153,285,399 shares under its 15% placement capacity (under ASX Listing Rule 7.1) and its 10% placement capacity (under ASX Listing Rule 7.1A). Tranche 2 totals A$3,250,000 of proceeds and the issuance of 65,000,000 shares, and settlement is contingent upon shareholder approval at Extraordinary General Meeting to be held in July 2018.



Hyperfine Adds Medtech Leader and Visionary Scott Huennekens as Executive Chairman

Mr. Huennekens’ public boards include Chairman of Acutus Medical (IPO August 2020); Chairman of Envista (IPO September 2019); and board member of Nuvasive. He also serves as a board member and past Chairman of the Medical Device Manufacturer’s Association (MDMA).

One Drop Reports Carrie Siragusa, CPA Appointed VP of Commercial Strategy, Biosensor

Formerly Head of Innovation and Diabetes Portfolio at Sanofi, Siragusa will be part of a team bringing a multi-analyte dermal sensor (biosensor) with continuous health sensing capabilities to market with a mission to provide broader access to continuous glucose monitoring.

Barbara Moorhouse Appointed as Medica Non-Executive Director

Barbara has extensive business and management experience in the private, public, and regulated sectors.

Subscribe to Medical Device News Magazine here.

Related Articles

Join our list

Subscribe to our mailing list and receive an end-of-week recap news and updates delivered right to your email inbox.