AbSolutions Med, Inc. Receives FDA Breakthrough Device Designation for its REBUILD™ Bioabsorbable Abdominal Wall Closure Device

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MOUNTAIN VIEW, Calif., Jan. 24, 2024 (GLOBE NEWSWIRE) -- AbSolutions Med, Inc., a privately held medical device company, announced today that the Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its REBUILD Bioabsorbable (“REBUILD”) abdominal wall closure device.

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GlobeNewswire, Inc.

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Jeudi, janvier 25, 2024

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Patient, Incisional hernia, General surgery, Abdominal wall, Medicine, Risk, Quality of life, Disease, Food, FDA, Three-body problem, Laparotomy

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MOUNTAIN VIEW, CA, US

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Résumé

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MOUNTAIN VIEW, Calif., Jan. 24, 2024 (GLOBE NEWSWIRE) -- AbSolutions Med, Inc., a privately held medical device company, announced today that the Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its REBUILD Bioabsorbable (“REBUILD”) abdominal wall closure device.
REBUILD met the criteria set by the FDA for Breakthrough Devices, potentially providing a novel treatment of an often irreversibly debilitating condition: incisional hernia.
Since the first documented laparotomy in 1809, general surgery has been challenged by its limitations in reliably managing a basic but fundamental aspect of abdominal surgery – closure of the abdominal wall.
The impact of a failed abdominal closure can be devastating, with lifelong debilitation, morbidity, and re-operation occurring in a large percentage of patients.

MOUNTAIN VIEW, Calif., Jan. 24, 2024 (GLOBE NEWSWIRE) -- AbSolutions Med, Inc., a privately held medical device company, announced today that the Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its REBUILD Bioabsorbable (“REBUILD”) abdominal wall closure device. REBUILD met the criteria set by the FDA for Breakthrough Devices, potentially providing a novel treatment of an often irreversibly debilitating condition: incisional hernia. Less than 7% of Breakthrough Devices are in the field of general surgery, making REBUILD a standout product in a sector of medicine struggling to make profound advances.

Since the first documented laparotomy in 1809, general surgery has been challenged by its limitations in reliably managing a basic but fundamental aspect of abdominal surgery – closure of the abdominal wall. Clinical failure of the closure from sutures tearing through tissue leads to incisional hernia in up to 35.6% of cases¹. The impact of a failed abdominal closure can be devastating, with lifelong debilitation, morbidity, and re-operation occurring in a large percentage of patients.

REBUILD supports the abdominal wall closure by distributing suture tension over a large area of tissue to maintain apposition of the midline fascial structures during the critical period of healing after surgery, and is then absorbed so as to minimize the risk of long-term foreign body complications. REBUILD has been tested in both animal and human studies with promising outcomes.

“The field of hernia repair and hernia prevention has been dominated exclusively by various mesh products. REBUILD takes a different approach, focusing on the root cause of the problem by supporting intrinsic tissue healing, designed to eliminate long-term foreign bodies, and potentially improving patient quality of life by breaking the vicious cycle of repairs, complications and re-operations,” said Dr. Daniel Jacobs, CEO of AbSolutions Med, Inc.

About REBUILD

REBUILD is intended to support soft tissue approximation of the abdominal wall in conjunction with suture by distributing tension to maintain apposition of the rectus muscles during healing, which has been associated with reduction in post-operative ventral hernia formation. REBUILD is not cleared by the FDA and is not for sale.

About AbSolutions Med, Inc.

AbSolutions Med, Inc. is a medical device company with the vision to move beyond mesh and rebuild abdominal wall integrity while maintaining normal anatomy and function.

For more information, please contact [email protected] or call 1-833-4-ABSMED (1-833-422-7633).

¹ Bosanquet DC, Ansell J, Abdelrahman T, Cornish J, … Torkington J (2015) Systematic Review and Meta-Regression of Factors Affecting Midline Incisional Hernia Rates: Analysis of 14,618 Patients. PLoS ONE 10(9): e0138745. DOI: 10.1371/journal.pone.0138745