Habeo Cell Therapy (ECCS-50) / Plus Therap - LARVOL DELTA

Safety and Effectiveness ofAutologous Adipose Tissue Derived Stromal Vascular Fraction Injection for Treatment of Eerectile Dysfunction (AUA 2018) - P1/2; "...Aspirated adipose tissue was processed using Celution 800/CRS System (Cytori Therapeutics Inc)... The study showed that effects of SVF injection contribute to recovery of erectile function. Results were confirmed by improvement of arterial blood flow and recovery of endothelial function. The proposed technique is safe and effective therefore it may be recommended as alternative treatment method of ED."

Clinical • Biosimilar • Erectile Dysfunction

Smoking and Physical Activity Significantly Influence Stromal Vascular Fraction Cell Yield and Viability. (PubMed, Aesthetic Plast Surg) - "Many factors may influence SVF cell yield and viability. Our findings indicate that age and smoking significantly influenced SVF cell yield, age positively while smoking negatively. Increased physical activity had a negative correlation with SVF cell viability."

Journal • Aesthetic Medicine

ENDURE: A Disease-based Treatment Study for Diagnosed Osteoarthritis Utilizing Adipose-derived Regenerative Cells (clinicaltrials.gov) - P=N/A; N=250; Not yet recruiting; Sponsor: Sanford Health; Initiation date: Sep 2020 ➔ Dec 2020

Trial initiation date • Immunology • Osteoarthritis • Pain • Rheumatology

Autologous Adult Adipose-Derived Regenerative Cell Injection Into Chronic Partial-Thickness Rotator Cuff Tears (clinicaltrials.gov) - P=N/A; N=246; Recruiting; Sponsor: InGeneron, Inc.; Trial completion date: Nov 2020 ➔ Aug 2021

Trial completion date

Healing Osteoarthritic Joints in the Wrist With Adult ADRCs (clinicaltrials.gov) - P=N/A; N=40; Recruiting; Sponsor: InGeneron, Inc.; Trial completion date: Jun 2020 ➔ Jun 2021; Trial primary completion date: Mar 2020 ➔ Mar 2021

Clinical • Trial completion date • Trial primary completion date • Immunology • Osteoarthritis • Pain • Rheumatology

Safety of Adipose-derived Regenerative Cells Injection for Treatment of Osteoarthritis of the Facet Joint (clinicaltrials.gov) - P=N/A; N=40; Recruiting; Sponsor: InGeneron, Inc.; Trial primary completion date: Jul 2020 ➔ Jul 2021

Clinical • Trial primary completion date • Anesthesia • Immunology • Osteoarthritis • Pain • Rheumatology

University of Washington Alzheimer's Disease Research Center (UW ADRC) Imaging & Biomarker Core (clinicaltrials.gov) - P; N=300; Not yet recruiting; Sponsor: University of Washington

Biomarker • New trial • Alzheimer's Disease • CNS Disorders

A Disease-based Treatment Study for Diagnosed Osteoarthritis Utilizing Adipose-derived Regenerative Cells (clinicaltrials.gov) - P; N=N/A; Withheld; Sponsor: [Redacted]

FDA event • New trial • Osteoarthritis • Pain • Rheumatology

Celution Prepared Adipose Derived Regenerative Cells in the Treatment of Osteoarthritis of the Knee (clinicaltrials.gov) - P2; N=90; Active, not recruiting; Sponsor: Cytori Therapeutics; Recruiting -> Active, not recruiting

Enrollment closed • Biosimilar • Immunology • Inflammation • Osteoarthritis • Pain

Characterization of Adipose Derived Regenerative Cells (ADRCs) From Patients With Chronic Heart Disease (clinicaltrials.gov) - P=N/A; N=20; Active, not recruiting; Sponsor: Cytori Therapeutics

New trial • Biosimilar • Cardiovascular • Heart Failure • Small Cell Lung Cancer

Cytori enters agreement with Idis to launch managed access program in EMEA (Businesswire) - "Cytori Therapeutics...announced today that it has entered into an agreement with Idis Managed Access, part of the Clinigen Group plc, to establish a Managed Access Program (MAP) in select countries across Europe, the Middle East, and Africa for patients with impaired hand function due to scleroderma. A MAP will allow Cytori, upon completion of the statutory legal and regulatory requirements, to offer patients and their healthcare providers access to...ECCS-50, in advance of the product’s full marketing authorization in their respective countries."

Regulatory • Systemic Sclerosis

Cytori Therapeutics: Annual Shareholders' Meeting (Cytori) - Anticipated data from P2 ATHENA trial in US for refractory heart failure in Q2 2014

Anticipated P2 data • Acute Coronary Syndrome

Autologous Adult Adipose-Derived Regenerative Cell Injection Into Chronic Partial-Thickness Rotator Cuff Tears (clinicaltrials.gov) - P=N/A; N=246; Not yet recruiting; Sponsor: InGeneron, Inc.

New trial • Biosimilar • Immunology

FDA approves expansion of pivotal scleroderma STAR trial to 20 clinical sites (Businesswire) - "Cytori Therapeutics...announced today that it received approval from FDA to expand the number of Scleroderma clinical trial sites from 12 to 20 centers in the United States."

Regulatory • Systemic Sclerosis

Cytori obtains Celution System approval in Singapore (Cytori Press Release) - "Cytori Therapeutics...has received approval from the Health Sciences Authority (HSA) in Singapore for the Celution® System for autologous re-implantation or re-infusion of a patient’s own adipose-derived regenerative cells (ADRCs). The Celution® System enables access to a patient’s own ADRCs at the point-of-care for a range of injuries and conditions."

Non-US regulatory • Acute Coronary Syndrome

Cytori’s Celution System approved in Australia for processing and delivering adipose-derived regenerative cells (Cytori Press Release) - "Cytori Therapeutics...Celution® System is approved for commercial use through inclusion on the Australian Registry of Therapeutic Goods for autologous re-implantation or re-infusion of a patient’s adipose-derived regenerative cells (ADRCs). The Celution® System produces autologous (a patient’s own) ADRCs at the point-of-care which may then be used for a range of injuries or conditions."

Non-US regulatory • Acute Coronary Syndrome

Cytori Therapeutics: ROTH Conference (Cytori) - "ADRCs may preserve functional capacity, improve perfusion, reduce scar, improve left ventricular contractility and lead to lower mortality"; "Safety: No malignant arrhythmias, adverse events similar in both groups"; "Harvesting ADRCs and transendocardial delivery is safe and feasible in patients with CAD"; "MVO2 & METS: Preserved function in ADRC at 6 & 18 months compared to controls (p=0.03, p=0.01)"; "Total Left Ventricular Mass (MRI): ADRC's demonstrated significant improvement over controls (p<0.001)"; "Wall Motion Score Index: ADCR's demonstrated significant improvement in wall motion score index (p<0.04) with a stabilization of scare size compared to controls"; "Inducible Ischemia (SPECT): was reduced in ADRCs patients up to 18 months (p<0.05)"; "Cardiac Mortality: At 27 months follow-up, fewer ADRC patient deaths compared to controls (1 of 21 in ADRCs vs 2 of 6 controls; p=0.10)"

P1 data • Acute Coronary Syndrome

Fat Grafts With Adipose-derived Regenerative Cells for Soft Tissue Reconstruction in Children (clinicaltrials.gov) - P=N/A; N=30; Active, not recruiting; Sponsor: Hospital Sirio-Libanes; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

EPIMSC: Intrathecal Autologous ADRC Treatment of Autoimmune Refractory Epilepsy (clinicaltrials.gov) - P1; N=6; Completed; Sponsor: Mossakowski Medical Research Centre Polish Academy of Sciences; Active, not recruiting ➔ Completed

Clinical • Trial completion • CNS Disorders • Epilepsy • Immune Modulation • Immunology

ADIPOSTEM: Intraspinal Transplantation of Autologous ADRC in ALS Patients (clinicaltrials.gov) - P1; N=30; Active, not recruiting; Sponsor: Mossakowski Medical Research Centre Polish Academy of Sciences; Recruiting ➔ Active, not recruiting; Trial completion date: Oct 2019 ➔ Oct 2022; Trial primary completion date: Oct 2018 ➔ Oct 2020

Clinical • Enrollment closed • Trial completion date • Trial primary completion date • Amyotrophic Lateral Sclerosis • CNS Disorders • Complement-mediated Rare Disorders • Pain • Proteinopathy • Rare Diseases • Transplantation

Use of Adipose Derived Regenerative Cells in Bilateral Femoral Head Osteonecrosis (clinicaltrials.gov) - P1; N=25; Suspended; Sponsor: Mayo Clinic; Recruiting ➔ Suspended

Clinical • Trial suspension • MRI

Cytori warned of possible stock delisting (The San Diego Union-Tribune) - "Cytori Therapeutics has been warned by Nasdaq that its shares could be delisted from the exchange...Cytori can avoid delisting under Nasdaq rules by achieving a market value of at least $50 million for 10 consecutive business days by May 19, 2015...Cytori is sponsoring...testing the therapy to treat sclerodactyly caused by scleroderma."

Commercial • Financing

Safety of Adipose-derived Regenerative Cells Injection for Treatment of Osteoarthritis of the Facet Joint (clinicaltrials.gov) - P=N/A; N=40; Recruiting; Sponsor: InGeneron, Inc.; Trial completion date: Apr 2020 ➔ Jul 2021; Trial primary completion date: Mar 2020 ➔ Jul 2020

Clinical • Trial completion date • Trial primary completion date

Autologous Adipose-derived Regenerative Cells Injection for Treatment of Radiation-induced Rectovaginal Fistula (clinicaltrials.gov) - P1; N=16; Completed; Sponsor: South Ural State Medical University; Active, not recruiting ➔ Completed

Clinical • Trial completion

Use of Adipose Derived Regenerative Cells in Bilateral Femoral Head Osteonecrosis (clinicaltrials.gov) - P1; N=25; Recruiting; Sponsor: Mayo Clinic; Trial completion date: Jun 2022 ➔ Dec 2023; Trial primary completion date: Jun 2020 ➔ Dec 2021

Clinical • Trial completion date • Trial primary completion date • MRI