A Multicenter, Prospective, Randomized Controlled Modified Platform Trial Evaluating PURION Processed Lyophilized Human Amnion/Chorion Membrane (ppLHACM) and Standard of Care Versus Standard of Care Alone in the Treatment of Nonhealing Diabetic Foot Ulcers

This study will evaluate two human amnion/chorion membrane (ppLHACM) products and Standard of Care (SOC) versus SOC alone in the closure of nonhealing diabetic foot ulcers (DFUs).

开始日期2024-08-27

申办/合作机构

MiMedx Group, Inc.

[+1]

NCT06560502 / Not yet recruitingN/A

A Multicenter, Prospective, Randomized Controlled Modified Multi-Platform (Matriarch) Trial Evaluating Several Cellular, Acellular, and Matrix-like Products (CAMPs) and Standard of Care Versus Standard of Care Alone in the Management of DFUs and VLUs.

This is a multicenter, prospective, randomized controlled modified multi-platform (matriarch) trial evaluating several cellular, acellular, and matrix-like products (CAMPs) and standard of care versus standard of care alone in the management of nonhealing diabetic foot and venous leg ulcers.

开始日期2024-08-01

申办/合作机构

Stability Biologics LLC

[+1]

NCT06236750 / RecruitingN/A

A Post-Marketing Surveillance to Observe the Safety and Efficacy of Dehydrated Human Amnion/Chorion Membrane (DHACM) Wound Graft in the Management of Non-Ischemic Chronic Wounds

The purpose of this survey is to observe the efficacy and safety of EPIFIX® dehydrated human amnion/chorion membrane (DHACM) for the treatment of intractable diabetic foot ulcers or venous leg ulcers.

开始日期2023-08-04

申办/合作机构

MiMedx Group, Inc.

[+1]

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2024-05-01·Translational Andrology and Urology

Role of allogeneic placental tissues in penile inversion vaginoplasty

Article

作者: Satterwhite, Thomas ; Morrison, Shane D ; Shoham, Maia ; Hubbs, Brandon S ; Nolan, Ian T ; Michael, Georgina M ; Akhavan, Arya ; Gomez, Diego A

Background:

The role of allogeneic placental tissue (APT) in genital gender-affirming surgery (GAS) is not well understood. Penile inversion vaginoplasty (PIV), the most common genital GAS, often results in tissue healing- or wound-related complications, including scarring and neovaginal stenosis. Surgical reoperation and revision vaginoplasty are common. The aim of this study was to evaluate the contribution of APT to postoperative outcomes in PIV.

Methods:

The authors performed a retrospective analysis of consecutive adult patients undergoing primary PIV during a 6-year period (September 1, 2014 to September 1, 2020). Subjects receiving intraoperative application of an APT biomaterial were compared to those undergoing primary PIV without APT. Postoperative outcomes-including wound healing morbidity and reoperation-were compared between groups. Short- and long-term complications were classified using Clavien-Dindo.

Results:

A total of 182 primary PIV cases were reviewed (115 conventional PIV; 67 PIV-APT). The postoperative follow-up time for the population averaged 12.7 months. All-cause and wound related complications were significantly lower amongst PIV-APT patients when compared to conventional PIV (P=0.002 and P=0.004, respectively). The rate of long-term complications was significantly lower in PIV-APT subjects: prolonged pain (P=0.001), prolonged swelling (P=0.047), and neovaginal stenosis (P<0.001). The PIV-APT group required significantly less reoperation for vaginal depth enhancement (P=0.007).

Conclusions:

Though its use in urogenital reconstruction has been limited, this study indicates that the placement of APT during PIV significantly lowered the risk of complications associated with poor wound healing. This supports a novel use for placental tissues in reducing complications in genital GAS.

2024-03-01·Journal of wound care

Tri-layer amniotic membrane allografts: a versatile scaffold for managing acute and hard-to-heal wounds

Article

作者: Harper, John R ; Campbell, Shauna ; Massee, Michelle ; Moreno, Sarah

2024-03-01·Journal of wound care

Dehydrated human amnion/chorion membrane to treat venous leg ulcers: a cost-effectiveness analysis

Article

作者: Jong, Julie L De ; Oropallo, Alisha ; Tettelbach, William H ; Padula, William V ; Wahab, Naz ; Forsyth, R Allyn ; Magee, Gregory A ; Cohen, Benjamin G ; Hubbs, Brandon ; Kelso, Martha R ; Driver, Vickie ; Niezgoda, Jeffrey A ; Steel, Paul

Objective::

To evaluate the cost-effectiveness of dehydrated human amnion/chorion membrane (DHACM) in Medicare enrolees who developed a venous leg ulcer (VLU).

Method::

This economic evaluation used a four-state Markov model to simulate the disease progression of VLUs for patients receiving advanced treatment (AT) with DHACM or no advanced treatment (NAT) over a three-year time horizon from a US Medicare perspective. DHACM treatments were assessed when following parameters for use (FPFU), whereby applications were initiated 30–45 days after the initial VLU diagnosis claim, and reapplications occurred on a weekly to biweekly basis until completion of the treatment episode. The cohort was modelled on the claims of 530,220 Medicare enrolees who developed a VLU between 2015–2019. Direct medical costs, quality-adjusted life years (QALYs), and the net monetary benefit (NMB) at a willingness-to-pay threshold of $100,000/QALY were applied. Univariate and probabilistic sensitivity analyses (PSA) were performed to test the uncertainty of model results.

Results::

DHACM applied FPFU dominated NAT, yielding a lower per-patient cost of $170 and an increase of 0.010 QALYs over three years. The resulting NMB was $1178 per patient in favour of DHACM FPFU over the same time horizon. The rate of VLU recurrence had a notable impact on model uncertainty. In the PSA, DHACM FPFU was cost-effective in 63.01% of simulations at the $100,000/QALY threshold.

Conclusion::

In this analysis, DHACM FPFU was the dominant strategy compared to NAT, as it was cost-saving and generated a greater number of QALYs over three years from the US Medicare perspective. A companion VLU Medicare outcomes analysis revealed that patients who received AT with a cellular, acellular and matrix-like product (CAMP) compared to patients who received NAT had the best outcomes. Given the added clinical benefits to patients at lower cost, providers should recommend DHACM FPFU to patients with VLU who qualify. Decision-makers for public insurers (e.g., Medicare and Medicaid) and commercial payers should establish preferential formulary placement for reimbursement of DHACM to reduce budget impact and improve the long-term health of their patient populations dealing with these chronic wounds.

Declaration of interest::

Support for this analysis was provided by MiMedx Group, Inc., US. JLD, and RAF are employees of MiMedx Group, Inc. WHT, BH, PS, BGC and WVP were consultants to MiMedx Group, Inc. VD, AO, MRK, JAN, NW and GAM served on the MiMedx Group, Inc. Advisory Board. MRK and JAN served on a speaker's bureau. WVP declares personal fees and equity holdings from Stage Analytics, US.

项与 MiMedx Group, Inc. 相关的新闻（医药）

2024-10-08

·GlobeNewswire-Health Care

MIMEDX Points to The New York Times Article on the Vast Benefits of Placental Tissue

Story Featured Patients Treated with MIMEDX ProductsMARIETTA, Ga., Oct. 08, 2024 (GLOBE NEWSWIRE) -- MiMedx Group, Inc. (Nasdaq: MDXG) (“MIMEDX” or the “Company”) today highlighted the publication of a feature article on placental allografts for patients with hard-to-heal, acute and chronic wounds, which was published in today’s New York Times: “Her Face Was Unrecognizable After an Explosion. A Placenta Restored It.” The author underscored the benefits of placental allografts for a variety of wound care and surgical procedures and brought attention to the largely unknown opportunity for a mother to donate her nutrient rich placenta after a healthy C-section delivery. MIMEDX uses this source material to produce the majority of its product offerings today. Commenting on the article, Joseph H. Capper, MIMEDX Chief Executive Officer, stated, “We were delighted to see attention called to this area of patient care and to contribute to this important piece. While MIMEDX is not mentioned by name, two individuals from our “Patient Story” series, Marcella and Phyllis, are prominently featured in the article, showcasing their remarkable recoveries. In both cases our products played a central role.” Mr. Capper concluded, “We believe this article and the recently-published Nature – Scientific Reports publication will increase awareness about the unique scientific properties and growing clinical use of placental-derived products to treat patients with chronic and other hard-to-heal wounds.” About MIMEDXMIMEDX is a pioneer and leader focused on helping humans heal. With more than a decade of helping clinicians manage chronic and other hard-to-heal wounds, MIMEDX is dedicated to providing a leading portfolio of products for applications in the wound care, burn, and surgical sectors of healthcare. The Company’s vision is to be the leading global provider of healing solutions through relentless innovation to restore quality of life. For additional information, please visit www.mimedx.com. Contact:Matt NotarianniInvestor Relations470-304-7291mnotarianni@mimedx.com

2024-09-04

·PRNewswire

THIRD DEFENDANT FIGHTS BACK AGAINST MiMEDX, CLAIMING 'DISREPUTABLE AND UNLAWFUL BUSINESS PRACTICES'

Ex-MiMedx Employee Jake Heikkinen Files Counterclaims Alleging Schemes 'To Bilk Medicare' and 'Incentivize and Pressure Healthcare Providers' per Mintz Attorneys MARIETTA, Ga., Sept. 4, 2024 /PRNewswire/ -- The third of 10 defendants who were sued earlier this year by MiMedx Group, Inc. (NASDAQ: MDXG) today filed counterclaims against the company. Jake Heikkinen, a former MiMedx employee, states in the filing that he left the placental biologics company because of "MiMedx's schemes to bilk Medicare and other government and third-party taxpayers" and "'to incentivize and pressure healthcare providers to treat wounded veterans, diabetics, chronic wound sufferers and other patients with medically unnecessary or unsuitable products—all to the detriment of patients and the federal government." Heikkinen also formally presented his answers and defenses to MiMedx's lawsuit which claimed that the 10 former employees, who all recently left the company, allegedly breached their contractual obligations to MiMedx. The filing describes the MiMedx suit as a "blatant intimidation tactic." Specifically, the counterclaims by Heikkinen allege that MiMedx "engaged in and has directed members of its sales team including Mr. Heikkinen to engage in, predatory sales practices aimed at increasing its revenue by incentivizing fraud on the United States government, including Medicare fraud." The filing also states, "These examples are only the most recent in a long line of disreputable and unlawful business practices that MiMedx has engaged in." The claims reference a warning letter issued by the FDA to MiMedx's CEO, Joseph H. Capper, concerning its AXIOFILL product on December 20, 2023, and assert that this former employee and others felt "that the company had wasted the sales team's time claiming that there were no issues regarding AxioFill" even after receiving the letter, and that MiMedx's "lack of communication and transparency" regarding the facts were disturbing. The claims filed by Heikkinen's attorneys at Mintz and Fellows Labriola allege that he left MiMedx after "MiMedx tried to compel its employees to continue selling a product that the U.S. Food and Drug Administration ('FDA') determined could not lawfully be marketed without prior FDA approval." Today's counterclaims come on the heels of two other complaints filed this month on behalf of former MiMedx employees, Lora Whooley, and Caralyn Gargan. To read the Whooley claim, please click here HERE, and to read the Gargan claim, please click HERE. Caralyn Gargan's Lara Whooley's Counter Claim: SOURCE Mintz

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2024-08-26

·PRNewswire

DEFENDANT FIGHTS BACK AGAINST MiMEDX "BLATANT INTIMIDATION" NON-COMPETE SUIT

Ex-MiMedx Employee Caralyn Gargan Files Counterclaims for "Predatory Sales Practices" and "Incentivized Fraud" per Mintz Attorneys MARIETTA, Ga., Aug. 26, 2024 /PRNewswire/ -- One of 10 defendants who were sued earlier this year by MiMedx Group, Inc. (NASDAQ: MDXG) today filed counterclaims against the placental biologics company. Caralyn Gargan, a former MiMedx employee, filed the action against MiMedx for "predatory sales practices" and "incentivized fraud, including Medicare fraud." Gargan also formally presented her answers and defenses to MiMedx's lawsuit which claimed that the 10 former employees, who recently left the company, allegedly breached their contractual obligations to MiMedx. The filing describes the MiMedx suit as a "blatant intimidation tactic." Specifically, the counterclaims by Gargan allege that MiMedx "engaged in and has directed members of its sales team including [the former employee] to engage in, predatory sales practices aimed at increasing its revenue by incentivizing fraud on the United States government, including Medicare fraud." The claims reference a warning letter issued by the FDA to MiMedx's CEO, Joseph H. Capper, concerning its AXIOFILL product on December 20, 2023, and assert that the former employee and others "became increasingly uncomfortable about MiMedx senior leadership's direction to sell AxioFill, even though it had not been approved by (or even submitted to) the FDA for FDA Premarket Approval." The claims filed by Gargan's attorneys at Mintz and Fellows Labriola allege that she left MiMedx after "MiMedx tried to compel its employees to continue selling a product that the U.S. Food and Drug Administration ('FDA') determined could not lawfully be marketed without prior FDA approval." Today's counterclaims come on the heels of another filed earlier this month on behalf of another former MiMedx employee, Lora Whooley. To read the Gargan claim please click HERE. To read the Whooley claim, please click here HERE. SOURCE Mintz

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