Integra's CEO transition leaves cautious view unchanged, says Piper Sandler » 11:2606/2406/24/21
Piper Sandler analyst…
Integra LifeSciences CEO to step down to accept role of CEO of GE Healthcare » 08:3306/2406/24/21
Avita Medical management to meet virtually with BTIG » 06:1906/2406/24/21
Virtual Meeting to be…
|Over a week ago|
Avita Medical Q4 results show demand is growing, says Piper Sandler » 04:5706/1606/16/21
Piper Sandler analyst…
Piper Sandler analyst Matt O'Brien reiterates an Overweight rating on Avita Medical with a $27 price target after the company announced preliminary fiscal Q4 results, with revenue expectations of $9.5-$9.7M, which is over $1M greater than prior guidance at the mid-point. The upside seems to be driven by both Recell sales and BARDA related revenue as there has been a greater amount of burn accidents coming out of the pandemic than anticipated, and the company is continuing to capture share in this market, O'Brien tells investors in a research note. "There's a lot to like here over both the near and longer term," says the analyst.
Avita Medical raises Q4 revenue view to $9.5M-$9.7M from $8.2M-$8.6M » 18:1206/1506/15/21
Consensus is for Q4…
Consensus is for Q4 revenue $7.74M. AVITA Medical announced preliminary, unaudited financial results for the Q4. For the Q4 AVITA Medical has to date realized total revenue in excess of its Q4 guidance range of $8.2M-$8.6M. Based on the strength of both RECELL commercial revenue and BARDA related revenue, the Company is raising fiscal Q4 guidance to $9.5M-$9.7M, consisting of $6.0M-$6.2M of RECELL commercial revenue and $3.5M of RECELL revenue associated with BARDA, the U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority within the Office of the Assistance Secretary for Preparedness and Response. RECELL commercial revenue as revised in the guidance reflects a 55%-60% increase over the prior year period and 30%-34% increase over the Q3. "As people begin to return to normal activities after the confines of the COVID-19 pandemic, we have seen an increase in burn accidents requiring treatment with the RECELL System in burn centers across the country," said Mike Perry, AVITA Medical's CEO.
Avita Medical's RECELL System approved by FDA for treating pediatric patients » 09:0406/1006/10/21
AVITA Medical announced…
AVITA Medical announced that the Food and Drug Administration has approved expanded use of the RECELL System in combination with meshed autografting for the treatment of all sizes of acute full-thickness thermal burn wounds for both pediatric and adult patients. Specifically, RECELL is now indicated to treat full-thickness thermal burns in patients 1-month of age and older. In addition, the indication now includes treatment for full-thickness thermal burns that extend beyond 50% total body surface area. The revised indication for the RECELL System is based on clinical data from the RECELL Compassionate Use and Continued Access studies. As Biomedical Advanced Research and Development Authority's, or BARDA, mandate includes building preparedness by expanding the indications of medical countermeasures for vulnerable populations, such as pediatrics, an independent contract option dedicated to this goal was exercised between BARDA and AVITA Medical in support of a pediatric burn clinical trial. For full-thickness burns, the initial PMA study of RECELL treatment was limited to patients with burn wounds up to 50% TBSA injuries, which was also reflected in the initial FDA-approved RECELL indication. The updated indication no longer constrains treatment of full-thickness injuries based on an upper limit of 50% TBSA. The median number of autograft procedures for patients with extensive burns treated with RECELL under Compassionate Use was two, versus a matching cohort of patients in the National Burn Registry for which the median number of autograft treatments was five.
MediWound completes enrollment for interim assessment of EscharEx Phase 2 study » 16:3106/0906/09/21
MediWound Ltd. announced…
MediWound Ltd. announced that the enrollment target of patients for an interim assessment of its EscharEx U.S. phase 2 adaptive design study for the treatment of venous leg ulcers has been achieved, and interim assessment is expected by the end of July 2021. The pre-defined interim assessment is for futility analysis and potential sample size adjustment. This study, which is targeted to enroll a total of 120 patients by year-end 2021, is designed to assess the safety and efficacy of EscharEx compared to gel vehicle and non-surgical standard-of-care. "We are very pleased to reach this important clinical milestone, and we look forward to the interim assessment next month," said Sharon Malka, Chief Executive Officer of MediWound. "With a clear unmet medical need for a non-surgical rapid and effective debridement agent in the outpatient setting, EscharEx has the potential to improve on the current standard of care and have a meaningful impact on chronic wound management. EscharEx represents a significant market opportunity for MediWound, with an addressable market of over a billion dollars annually." As part of the Company's broader EscharEx development program, MediWound is also conducting a phase 2 open-label, single arm study assessing the pharmacological effects of EscharEx in up to 15 patients with both diabetic foot ulcers and VLUs. The objective of this study is to gain a better understanding of what is happening in the wound bed, both during and after debridement with EscharEx, and to assess its effect on biofilm burden, reduction in inflammation, and the initiation of wound healing. MediWound expects to generate data from this study in the second half of 2021.
MediWound announces peer-reviewed paper on basal cell carcinoma » 07:2706/0706/07/21
MediWound announced that…
MediWound announced that a peer-reviewed publication of a case series report of basal cell carcinoma destruction by a concentrate of proteolytic enzymes enriched in bromelain has been published in the Open Dermatology Journal. MediWound anticipates initiating a phase I/II clinical study of MW005 for the treatment of BCC this month, with data expected by the end of 2021. The paper, entitled Basal Cell Carcinoma Destruction by a Concentrate of Proteolytic Enzymes Enriched in Bromelain: A Preliminary Report, details case series experience using a concentrate of proteolytic enzymes enriched in bromelain for the destruction of six BCC tumors. Six BCCs located on the face, neck, and extremities were self-treated by three patients with 2-6 applications. All of the BCCs were completely removed and two of the lesion's sites were surgically excised after 6 months with no tumor cells noted on histopathology. None of the BCCs recurred over the subsequent year. The findings provide a preliminary proof-of-concept that a concentrate of proteolytic enzymes enriched in bromelain may be a safe and effective destructive treatment for basal cell carcinomas. BCC is a non-melanoma skin cancer that arises from the basal layer of epidermis and its appendages. According to the American Cancer Society, BCC is the most diagnosed skin cancer in the United States with approximately 4.3 million diagnosed cases every year. The increasing number of diagnosed BCC is a result of better skin cancer detection, increased sun exposure, and greater life expectancy.
Vericel appoints Lisa Wright to its Board of Directors, effective immediately » 08:4606/0206/02/21
Vericel announced the…
Vericel announced the appointment of Lisa Wright to its Board of Directors, effective immediately. Ms. Wright will serve as a member of the Governance and Nominating Committee of the Board. With the appointment of Ms. Wright, Vericel's Board is now comprised of eight directors, seven of whom are independent. Ms. Wright is President and Chief Executive Officer of Community Health Choice, Inc., a managed care organization with approximately 430,000 members and a provider community consisting of over 10,000 physicians and 100 hospitals in the greater Houston, Texas area. Previously, Ms. Wright served as a Regional President, Medicare, at WellCare Health Plans, Inc., President of Dual Special Needs Plan, Medicare-Medicaid Plan and Nursing Facilities at UnitedHealth Group, Inc., and in marketing programs management at Anthem, Inc. Ms. Wright currently serves on the boards of directors of several non-profit organizations. She received a Bachelor of Arts degree in Communication from the University of Kentucky and a Master of Business Administration from the University of Maryland, University College system.
Organogenesis to replace Crocs in S&P 600 at open on 6/2 04:5506/0206/02/21