Posts

Kerastem Issued Patent for Groundbreaking Hair Growth Technology

Kerastem Issued Patent for Groundbreaking Hair Growth Technology

Kerastem Issued Patent for Groundbreaking Hair Growth Technology

Kerastem Hair Growth

Company has successfully completed 12-month follow-up of US Phase II clinical trial (STYLE). The Kerastem Therapy is CE mark approved for patients with alopecia in Europe

Kerastem, the global leader in the development and commercialization of regenerative medicine-based approaches to hair growth has received U.S. Patent Number 9,931,436 (the ‘436 patent).

The ‘436 patent protects the current Kerastem technology and also covers a vast array of fat, stem cell and platelet rich plasma systems and methods for hair growth.

“The issuance of our Kerastem patent by the United States Patent and Trademark Office reinforces the protectability of our novel Kerastem technology,” said Bradford A. Conlan, CEO of Kerastem.

The company recently reported 12-month top-line data from its clinical trial (STYLE), a 70 patient, phase II, US multi-center, randomized, single-blinded, and controlled study investigating Kerastem’s therapy in patients with hair loss.*

The Kerastem therapy is a one-time treatment that utilizes adipose (fat) derived regenerative cells delivered to the affected area of scalp. “The company is poised for success considering the excellent results observed from our US phase II clinical trial where a specific dose was identified that grows hair.”

About Kerastem 

Kerastem is a wholly owned subsidiary of Bimini Technologies. The Bimini portfolio also includes Puregraft (http://www.puregraft.com), the world’s leading fat transfer solution.

In 15 minutes or less, the Puregraft products provide surgeons with purified fat for reinjection and are used in hospitals and clinics around the world. The existing Puregraft customer base are ideal prospects for the new Kerastem technology.

Androgenetic Alopecia Market Size

Hair loss affects more than 40 million men and 21 million women and in the United States alone. The global hair loss treatment market generates more than $7 Billion annually and currently has limited options for men (grades I-III) and women (grades I-II) with early stage hair loss.

Source

*Source: IDE# 16488-STYLE, ClinicalTrials.gov identifier (NCT number): NCT02503852

Kerastem Hair Growth Trial

Kerastem Successful Hair Growth Trial

Kerastem Reports Successful US Phase II Hair Growth Clinical Trial Results

Kerastem reports 6-month top-line data from its clinical study STYLE, a 70 patient, phase II, US multi-center, randomized, single-blinded, and controlled clinical trial investigating Kerastem’s therapy in patients with early stage hair loss.

The Kerastem therapy is a one-time treatment that utilizes adipose (fat) derived regenerative cells combined with purified fat delivered to the affected area of scalp.

  • Low dose Adipose Derived Regenerative Cells (ADRC’s) + Puregraft fat treatment group achieved a statistically significant increase in mean terminal hair count, when compared to control, in males with early stage hair loss (Norwood Grades I-III). An average increase of 29 terminal hairs per cm2 of scalp was observed, corresponding to a 17% increase (p < 0.05) from baseline.
  • All treatment arms of STYLE were safe with no serious adverse events reported.

“The Kerastem team has successfully identified a treatment that stimulates hair growth in people with early stage hair loss,” stated Brad Conlan, CEO of Kerastem.  “There are over 40 million people with early stage hair loss in the United States alone.

Kerastem Successful Hair Growth Trial

Kerastem is poised to disrupt this market based upon the results from STYLE and is actively signing and exploring distribution relationships outside of the United States.  We are thrilled about the STYLE data and what it means for patients with early stage hair loss who have had very few treatment options to date.”

KERASTEM SUPERIOR TO OTHER CELL BASED TREATMENT CURRENTLY AVAILABLE

According to Dr. Eric Daniels, Kerastem’s Chief Medical Officer, “STYLE indicates that dosing and tissue preparation are essential to achieving a successful outcome.  Added Dr. Daniels, “We were very pleased to see the positive results from the low dose arm and were surprised that the high dose ADRC’s + Puregraft fat treatment group, along with the fat alone group, observed a reduction, or no change, respectively in terminal hair counts. Stated otherwise, dosing and tissue purity matter.”

To understand the STYLE results in context–the low dose treatment group had an average increase of 29 hairs per cm2 of scalp, which corresponds to an increase of 2,900 hairs per 100 cm2 of treated scalp.

While the average hair transplant today is between 1,900 to 2,200 transplanted hairs, patients with early hair loss are very often not candidates for hair transplantation.  Kerastem therapy represents a new option.  The therapy utilizes patented medical device technology to deliver a consistent cell therapy output, enabling appropriate dosing.

ANDROGENETIC ALOPECIA MARKET SIZE

Hair loss affects more than 40 million men and 21 million women and in the United States alone.  The global hair loss treatment market generates more than $7 Billion annually and currently has limited options for men (grades I-III) and women (grades I-II) with early stage hair loss.

ABOUT KERASTEM

Kerastem is the leader in the development and commercialization of cell-based approaches to hair growth. The company is a wholly owned subsidiary of Bimini Technologies. The Bimini portfolio also includes Puregraft, the world’s leading fat transfer solution.

Source Kerastem Successful Hair Growth Trial

Kerastem Issued Patent for Groundbreaking Hair Growth Technology

Kerastem UK Hair Growth Data Published

Kerastem UK Hair Growth Data Published

Kerastem, the leader in cell-based approaches to hair growth, announced today that clinical data utilizing the Kerastem therapy for the treatment of female and male patterned baldness (genetic alopecia) was published in the peer reviewed Journal of Stem Cells and Cloning.

The authors reported that all six (100%) subjects receiving Kerastem Therapy had an increase from baseline hair counts at 6 months, with initial results as early as 6 weeks.

The investigators performed a single scalp injection of Kerastem Cell Therapy in 9 healthy hair loss patients, and a total of 6 patients were followed for a period of 6 months.

The authors reported a mean increase of 31 hairs per cm2 of scalp at 24 weeks compared to baseline, corresponding to a 23% increase (p = 0.017).

Kerastem Therapy subjects saw up to a 53% increase in the number of hairs at 6 months.

According to lead investigator Dr. David Perez-Meza, “We are very pleased with the clinical outcomes of our hair regeneration study, as they represent this procedure is safe and that results that are on par or better than those of traditional medical approaches to hair loss.”

US PHASE II CLINICAL TRIAL ENROLLED (STYLE)

The Kerastem therapy is based on the emerging science that adipose (fat) plays an important role in the normal hair growth cycle.

The clinical approach utilizes purified adipose combined with stem and regenerative cells to deliver cell enriched tissue to the affected scalp. According to Dr. Eric Daniels, Chief Medical Officer of Kerastem, “Fat and fat derived cells are now appreciated as a dynamic, and vital participant in the normal cycle of hair growth.

This data set from the United Kingdom further supports this position and we look forward to releasing top-line 24-week data from our fully enrolled STYLE trial later this year.” Outside of the United States, the company is actively involved in market development, with Kerastem therapy currently being offered at a number of clinics in Europe & Japan.

To learn more about Kerastem or the STYLE Clinical Trial, please visit http://www.kerastem.com.

ANDROGENETIC ALOPECIA MARKET SIZE

Hair loss affects more than 21 million women and 40 million men in the United States alone. The global hair loss market is valued at more than $7 Billion and currently has limited options for women and men with early hair loss.

About Kerastem

Kerastem is a leader in the development and commercialization of cell-based approaches to hair growth. The private company is a wholly owned subsidiary of Bimini Technologies.

The Bimini portfolio also includes Puregraft, the world’s leading fat transfer solution.

Cautionary Statement Regarding Forward-Looking Statements

This press release may include “forward-looking statements” intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995.

These forward-looking statements generally can be identified by phrases such as “will,” “near future,” “positioned,” “provide,” or other words or phrases of similar import that are intended to identify forward-looking statements. Similarly, statements herein that describe Kerastem LLC’s business strategy, outlook, objectives, plans, intentions, or goals also are forward-looking statements.

All such forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from those in forward-looking statements, including: the clinical and commercial potential and success of the company’s product line; general economic and business conditions; and other risks and important factors that could cause actual results to differ materially from the forward-looking statements. The forward-looking statements included in this press release are made only as of the date of this announcement, and Kerastem LLC undertakes no obligation to update the forward-looking statements to reflect subsequent events or circumstances after the date on which they were made.

Source