Stratagraft (regenerative skin tissue) / Mallinckrodt - LARVOL DELTA

Impact on Inpatient Length of Stay in Adults with Deep Partial-Thickness Burns: Comparing the Bioengineered Allogeneic Cellularized Construct Expanded-Access Trial with National Burn Repository Data. (PubMed, Clinicoecon Outcomes Res) - "To investigate the effect of StrataGraft (bioengineered allogeneic cellularized construct [BACC]) treatment on inpatient length of stay (LOS) as an indicator of hospital resource utilization...An ad hoc analysis revealed that mean [SD] LOS for BACC and the weighted Autograft cohorts were 17.68 [12.75] and 22.51 [19.75] days, respectively, and were 1.39 [0.94] and 1.88 [1.31] days per %TBSA burned, respectively. The significantly reduced inpatient LOS observed with BACC compared to Autograft in adults with DPT burns may translate into reduced burden on the healthcare system, reduced costs for inpatient burn treatment, and clinical benefits for patients."

Journal • Cardiovascular • Diabetes • Hypertension • Metabolic Disorders • Thermal Injury

A phase 3b, open-label, single-arm, multicenter, expanded-access study of the safety and clinical outcomes of StrataGraft® treatment in adults with deep partial-thickness thermal burns. (PubMed, Burns) - P3 | "StrataGraft demonstrated clinical benefit. Safety data were consistent with previously reported findings."

Clinical data • Journal • P3 data • Cardiovascular • Dermatology • Infectious Disease • Myocardial Infarction • Pruritus • Septic Shock • Thermal Injury

StrataSOMA: StrataGraft Overlay of Meshed Autograft in Full-thickness Thermal Burns (clinicaltrials.gov) - P2 | N=13 | Completed | Sponsor: Stratatech, a Mallinckrodt Company | Active, not recruiting ➔ Completed | Trial completion date: Dec 2024 ➔ Mar 2024 | Trial primary completion date: Dec 2024 ➔ Mar 2024

Trial completion • Trial completion date • Trial primary completion date • Thermal Injury

StrataSTEPS: StrataGraft Safety, Tolerability and Efficacy in Pediatric Subjects (clinicaltrials.gov) - P3 | N=1 | Completed | Sponsor: Stratatech, a Mallinckrodt Company | Active, not recruiting ➔ Completed

Trial completion • Mood Disorders • Pediatrics • Thermal Injury

StrataSOMA: StrataGraft Overlay of Meshed Autograft in Full-thickness Thermal Burns (clinicaltrials.gov) - P2 | N=13 | Active, not recruiting | Sponsor: Stratatech, a Mallinckrodt Company | Trial completion date: Jan 2024 ➔ Dec 2024 | Trial primary completion date: Jan 2024 ➔ Dec 2024

Trial completion date • Trial primary completion date • Thermal Injury

StrataSOMA: StrataGraft Overlay of Meshed Autograft in Full-thickness Thermal Burns (clinicaltrials.gov) - P2 | N=13 | Active, not recruiting | Sponsor: Stratatech, a Mallinckrodt Company | Recruiting ➔ Active, not recruiting

Enrollment closed • Thermal Injury

StrataSTEPS: StrataGraft Safety, Tolerability and Efficacy in Pediatric Subjects (clinicaltrials.gov) - P3 | N=1 | Active, not recruiting | Sponsor: Stratatech, a Mallinckrodt Company | Recruiting ➔ Active, not recruiting | N=50 ➔ 1 | Trial completion date: Jun 2025 ➔ May 2024 | Trial primary completion date: Jun 2025 ➔ May 2024

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Mood Disorders • Pediatrics • Thermal Injury

The viable bioengineered allogeneic cellularized construct StrataGraft® synthesizes, deposits, and organizes human extracellular matrix proteins into tissue type-specific structures and secretes soluble factors associated with wound healing. (PubMed, Burns) - "The organization of the ECM proteins was like human skin and the viable cellular components provided sustained secretion of soluble wound healing factors, making StrataGraft an attractive option for treating severe burns."

Journal • Thermal Injury

StrataGraft® Skin Tissue Expanded Access at Specific Study Sites ( StrataCAT ) (clinicaltrials.gov) - P3 | N=52 | Completed | Sponsor: Stratatech, a Mallinckrodt Company | Approved for marketing ➔ Completed | Phase classification: PN/A ➔ P3

Phase classification • Trial completion • Thermal Injury

StrataSOMA: StrataGraft Overlay of Meshed Autograft in Full-thickness Thermal Burns (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Stratatech, a Mallinckrodt Company | Trial completion date: Jun 2023 ➔ Nov 2023 | Trial primary completion date: Jun 2023 ➔ Nov 2023

Trial completion date • Trial primary completion date • Thermal Injury

StrataSTEPS: StrataGraft Safety, Tolerability and Efficacy in Pediatric Subjects (clinicaltrials.gov) - P3 | N=50 | Recruiting | Sponsor: Stratatech, a Mallinckrodt Company | Not yet recruiting ➔ Recruiting

Enrollment open • Mood Disorders • Pediatrics • Thermal Injury

Scarring in Stratagraft-treated vs. Autograft-treated Burn Wounds: a Clinical and Histological Investigation (clinicaltrials.gov) - P=N/A | N=5 | Active, not recruiting | Sponsor: Medstar Health Research Institute | Recruiting ➔ Active, not recruiting | N=14 ➔ 5 | Trial completion date: Oct 2022 ➔ Jun 2023

Enrollment change • Enrollment closed • Trial completion date

StrataSTEPS: StrataGraft Safety, Tolerability and Efficacy in Pediatric Subjects (clinicaltrials.gov) - P3 | N=50 | Not yet recruiting | Sponsor: Stratatech, a Mallinckrodt Company

New P3 trial • Pediatrics • Thermal Injury

Pooled safety analysis of STRATA2011 and STRATA2016 clinical trials evaluating the use of StrataGraft® in patients with deep partial-thickness thermal burns. (PubMed, Burns) - P1, P3 | "StrataGraft was well tolerated by patients, with a safety profile similar to autograft. StrataGraft may offer a safe alternative to autograft for DPT burns."

Journal • Cardiovascular • Dermatology • Hypertension • Immunology • Pruritus • Thermal Injury

Scarring in Stratagraft-treated vs. Autograft-treated Burn Wounds: a Clinical and Histological Investigation (clinicaltrials.gov) - P=N/A | N=14 | Recruiting | Sponsor: Medstar Health Research Institute | Not yet recruiting ➔ Recruiting | Trial completion date: Oct 2021 ➔ Oct 2022 | Initiation date: Jul 2021 ➔ Feb 2022 | Trial primary completion date: Oct 2021 ➔ Oct 2022

Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date

StrataSOMA: StrataGraft Overlay of Meshed Autograft in Full-thickness Thermal Burns (clinicaltrials.gov) - P2; N=40; Recruiting; Sponsor: Stratatech, a Mallinckrodt Company; Not yet recruiting ➔ Recruiting; Trial completion date: Oct 2022 ➔ Jun 2023; Trial primary completion date: Oct 2022 ➔ Jun 2023

Clinical • Enrollment open • Trial completion date • Trial primary completion date • Complement-mediated Rare Disorders • Thermal Injury

"Keeping Track: StrataGraft Continues US FDA’s Biologic Center Approvals Streak; Another CRL For Avenue’s Tramadol IV https://t.co/IjA0KRllV8 #PinkSheet" (@PharmaPinkSheet)

FDA event

A phase 3, open-label, controlled, randomized, multicenter trial evaluating the efficacy and safety of StrataGraft® construct in patients with deep partial-thickness thermal burns. (PubMed, Burns) - P3 | "Both coprimary endpoints were achieved. StrataGraft may offer a new treatment for DPT burns to reduce the need for autografting."

Clinical • Journal • P3 data • Complement-mediated Rare Disorders • Dermatology • Pruritus • Thermal Injury

Scarring in Stratagraft-treated vs. Autograft-treated Burn Wounds: a Clinical and Histological Investigation (clinicaltrials.gov) - P; N=14; Not yet recruiting; Sponsor: Jeffrey Shupp

Clinical • New trial

StrataSOMA: StrataGraft Overlay of Meshed Autograft in Full-thickness Thermal Burns (clinicaltrials.gov) - P2; N=40; Not yet recruiting; Sponsor: Stratatech, a Mallinckrodt Company

Clinical • New P2 trial • Complement-mediated Rare Disorders • Thermal Injury

An open-label, prospective, randomized, controlled, multicenter, phase 1b study of StrataGraft skin tissue versus autografting in patients with deep partial-thickness thermal burns. (PubMed, Burns) - "StrataGraft tissue treatment of DPT thermal burns reduced the need for autograft, resulted in wound closure and treatment-site cosmesis comparable to that of autograft, and was well tolerated."

Clinical • Journal • P1 data • Complement-mediated Rare Disorders • Dermatology • Pruritus • Thermal Injury

"Mallinckrodt StrataGraft Skin Therapy Could Be The First RMAT-Designated Therapy Approved By US FDA https://t.co/go1v1EYKE6 #PinkSheet" (@PharmaPinkSheet)

FDA event

"Mallinckrodt Reports Completion of BLA Submission to the US FDA for StrataGraft to Treat Deep Partial-Thickness Thermal Burns in Adults @MNK https://t.co/bouwbP147C" (@Pharmashot)

Clinical • Complement-mediated Rare Disorders • Thermal Injury

"$MNK Completes Rolling Submission Of BLA For StrataGraft Regenerative Skin Tissue" (@BioStocks)

"@bradloncar Any thoughts on the potential revenue for Terlipressin from @MNK ? Any opinion on Stratagraft from same? Thank you!" (@Venturinglist)