Vericel Announces Publication of Positive Results from Retrospective Study by the Burn and Reconstructive Centers of America (BRCA) of Patients with Large Posterior Trunk Burns Treated with Epicel

Rhea-AI Summary

Data published in the Journal of Burn Care & Research highlights a retrospective study on 40 patients with significant posterior burns treated with Epicel by the Burn and Reconstructive Centers of America. Key findings include an 83% engraftment success rate after one or two applications and a 90% survival rate. The study underscores the effectiveness of standardized treatment protocols for enhancing patient outcomes in severe burns. Epicel is approved for deep dermal or full-thickness burns covering at least 30% of total body surface area.

Positive

• 83% engraftment success rate after one or two applications of Epicel.
• 90% survival rate for patients treated with Epicel.

Negative

• None.

• Data published in the Journal of Burn Care & Research show 83% of patients with posterior burns (mean total body surface area of 56%) had successful engraftment of Epicel after one or two applications
  
• 90% survival rate following Epicel and/or Epicel plus split thickness skin graft
• Study demonstrates that standardized treatment protocols and surgical plans for Epicel use developed by the BRCA result in positive patient outcomes
  

CAMBRIDGE, Mass., July 21, 2022 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced the publication of results from a retrospective study conducted by the Burn and Reconstructive Centers of America (BRCA) of 40 patients with large posterior trunk burns treated with Epicel® (cultured epidermal autografts) in the Journal of Burn Care & Research. Severe burns on posterior trunk surfaces present special consideration since the posterior surfaces bear the major portion of the body weight. The study evaluated the success of engraftment in patients receiving Epicel for posterior trunk burns with total burn surface area (TBSA) ≥30% treated at three high-volume burn centers within the BRCA between March 2016 and December 2019.

“This valuable first of its kind study shows that the development of standard treatment protocols and surgical plans, based on experience with a high volume of burn patients treated within the Burn and Reconstructive Centers of America, have enabled positive outcomes with cultured epidermal autografts in large severe burns, including posterior burns,” said Bounthavy Homsombath, M.D., Burn Medical Director, Joseph M. Still Burn Center at Doctors Hospital of Augusta.

The retrospective study consisted of 40 patients with a mean age of 38 years (68% male, 32% female) with burn etiology fire/flame (78%). The mean TBSA was 56% (range 30% to 95%), with a mean revised BAUX Score of 97 (range 49 to 141). The location of the burns on the posterior trunk were ‘back only' (55%), ‘back and buttocks’ (27.5%), and ‘buttocks only' (5%). The median percentage of area covered by burn in all three categories was 100%. Key findings include:

• 83% (33/40) of patients with posterior burns had successful engraftment after one or two applications of Epicel.
  • 70% (28/40) of patients treated had successful engraftment after one application of Epicel. These patients had younger mean age, lower mean %TBSA, burn location on the posterior trunk of the back only (vs. back and buttocks or buttocks only), and Epicel was applied over split thickness skin graft (STSG).
• 90% survival rate following one or two applications with Epicel and/or Epicel plus STSG.
  • Of the four patients who died, three were ≥55 years of age (range 55 to 71 years) with %TBSA ≥42% (range 42% to 74%), the fourth patient was under 18 with 95% TBSA.
  • The mean revised BAUX Score for these four patients was 122 (range 111 to 129) which is associated with an approximately 67% mortality (33% survival) rate.¹
    

“We are pleased to have these data published in a peer-reviewed journal, as it reinforces Epicel as an important therapy for patients with significant posterior burns,” said Dr. Jon Hopper, Chief Medical Officer of Vericel. “These data allow physicians to better identify key factors for successful treatment of large posterior burns with Epicel and could lead to significant improvements in real-world patient outcomes as demonstrated in this retrospective study.”

About Epicel

Epicel® (cultured epidermal autografts) is authorized for use in adult and pediatric patients who have deep dermal or full thickness burns comprising a total body surface area greater than or equal to 30%. It may be used in conjunction with split-thickness autografts, or alone in patients for whom split-thickness autografts may not be an option due to the severity and extent of their burns. The effectiveness of the device for this use has not been demonstrated.

For more information concerning Epicel and its use, including Important Safety Information, please visit the Epicel product website at www.epicel.com.

About Vericel Corporation

Vericel is a leader in advanced therapies for the sports medicine and severe burn care markets. The company markets two cell therapy products in the United States. MACI^® (autologous cultured chondrocytes on porcine collagen membrane) is an autologous cellularized scaffold product indicated for the repair of symptomatic, single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults. Epicel^® (cultured epidermal autografts) is a permanent skin replacement for the treatment of patients with deep dermal or full thickness burns greater than or equal to 30% of total body surface area. The company also holds an exclusive license for North American rights to NexoBrid^®, a registration-stage biological orphan product for debridement of severe thermal burns. For more information, please visit www.vcel.com.

Epicel^® and MACI^® are registered trademarks of Vericel Corporation. NexoBrid^® is a registered trademark of MediWound Ltd. and is used under license to Vericel Corporation. © 2022 Vericel Corporation. All rights reserved.

About Burn and Reconstructive Centers of America

In 1978 Dr. Joseph M. Still dedicated one hospital bed to burn patients and kickstarted what would become Joseph M. Still (JMS) Burn Centers Inc. Today, JMS Burn Centers Inc., falls under Burn and Reconstructive Centers of America (BRCA), a national system of burn care providers dedicated to Healing Patients. Healing Families. Healing Lives®. Headquartered at the nation's largest individual burn center in Augusta, GA, BRCA is the most extensive system of burn care in the United States. BRCA’s physicians and advanced practice providers treat patients of all ages for various injuries, including thermal, chemical and electrical burns, skin and soft tissue disorders, complex wounds and traumatic extremity injuries. Our system offers unsurpassed care that extends beyond the walls of our burn centers, beginning with an initial injury through long-term rehabilitation and reconstructive procedures. For more information, visit BRCA’s website at burncenters.com.

Investor Contact:

Eric Burns
ir@vcel.com 
+1 (734) 418-4411

Media Contact:

Julie Downs
jdowns@vcel.com 

1. Osler T, Glance LG, Hosmer DW. Simplified estimates of the probability of death after burn injuries: extending and updating the baux score. J Trauma. 2010 Mar;68(3):690-7. doi: 10.1097/TA.0b013e3181c453b3. PMID: 20038856.

FAQ

What were the results of the Epicel study published on July 21, 2022?

The study reported an 83% engraftment success rate and a 90% survival rate among patients with posterior burns treated with Epicel.

How many patients were involved in the Epicel study?

The study involved 40 patients with significant posterior burns.

What does a successful engraftment of Epicel mean for patients?

Successful engraftment indicates effective healing and recovery of skin in burn patients.

What type of burns is Epicel used for?

Epicel is used for deep dermal or full-thickness burns covering at least 30% of total body surface area.

Which journal published the Epicel study?

The study was published in the Journal of Burn Care & Research.