Creative Medical Technology Holdings Profile
Creative Medical Technology Holdings, Inc., through its wholly owned subsidiary, Creative Medical Technologies, Inc. (CMT), operates as a commercial stage biotechnology company dedicated to the advancement of identifying and translating novel biological therapeutics in the fields of immunotherapy, endocrinology, urology, neurology, and orthopedics.
The company's subsidiary, Creative Medical Technologies, Inc. (CMT), was originally created to monetize the U.S. Patent No. 8,372,797 and related intellectual property related to the treatment of erectile dysfunction (ED), which it acquired in May 2016. Subsequently, the company has expanded its development and acquisition of intellectual property beyond urology to include therapeutic treatments utilizing 're-programmed' stem cells, and the treatment of neurologic disorders, lower back pain, Type-1 diabetes, and heart, liver, kidney, and other diseases using various types of stem cells through its ImmCelz, Inc., StemSpine, Inc. and AlloCelz LLC subsidiaries. However, neither ImmCelz Inc. nor AlloCelz LLC have commenced commercial activities.
The company conducts substantially all of its commercial operations through CMT, which markets and sells its CaverStem and FemCelz disposable kits utilized by physicians to perform autologous procedures that treat erectile dysfunction and female sexual dysfunction, respectively. The company's CaverStem and FemCelz kits are available through physicians at eight locations in the United States.
In 2020, through its ImmCelz Inc. subsidiary, the company began developing treatments that utilize a patient's own extracted immune cells that are then 'reprogrammed/supercharged' by culturing them outside the patient's body with optimized cell-free factors. The immune cells are then re-injected into the patient from whom they were extracted. This process endows the immune cells with regenerative properties that may be suitable for the treatment of multiple indications. In contrast to other stem cell-based approaches, the immune cells are significantly smaller in size than stem cells and are believed to more effectively penetrate areas of the damaged tissues and induce regeneration.
In June 2022, the company signed an agreement with Greenstone Biosciences Inc. for the development of a human induced pluripotent stem cell (iPSC) pipeline for its ImmCelz platform. This project was identified as iPScelz. The efforts by Greenstone Biosciences Inc. are expected to complement and expand its work on novel therapeutic cell lines.
In October 2022, the company announced the development of its AlloStem Clinical Cell Line, a proprietary allogenic cell line which includes a Master Cell Bank and a Drug Master File. The company will be able to use this cell line for many of its programs, including its ImmCelz immunotherapy platform for multiple diseases, OvaStem for Premature Ovarian Failure, CELZ-201 for Type 1 diabetes, StemSpine for lower back pain, and IPScelz inducible pluripotent stem cell program in ongoing development with Greenstone Biosciences.
In November 2022, the company announced that the U.S. Food and Drug Administration (FDA) had cleared its CELZ-201 Investigational New Drug (IND) application for the treatment of Type 1 Diabetes, which will allow it to begin a Phase I/II clinical trial. The primary objective of the study will be to evaluate CELZ-201 in patients with newly diagnosed Type 1 Diabetes. Patient recruitment is expected to begin in 2023.
In addition to its clinical research efforts, the company is seeking to expand the commercial sale and use of its CaverStem and FemCelz products by physicians in the United States.
Products
CaverStem - Erectile Dysfunction Treatment
CaverStem is a clinically proven, patented procedure (U.S. Patent No. 8,372,797) that utilizes a patient's own stem cells to treat erectile dysfunction (ED). The procedure has been demonstrated safe and effective in clinical trials and is geared to the estimated nine million men in the United States that suffer from ED and do not respond to PDE5 inhibitors in drugs, such as Viagra and Cialis due to damage to smooth muscle and blood vessels.
The company's CaverStem stem cell treatment consists of a one-hour out-patient visit in a physician's office. The physician harvests a patient's stem cells from bone marrow in the hip using a local anesthetic. The extraction device is designed to harvest only the stem cells, while filtering out the red blood cells, thereby eliminating the need for any centrifugation. The stem cells are then injected into the patient's corpus cavernosum (erectile tissue) to stimulate muscle and blood vessel regeneration. Clinical research data concludes that the company's CaverStem treatment results in a marked increase in duration and frequency of erections and the ability to sustain erections until orgasm, with no known treatment-associated adverse events.
The company generates revenues through the sale of disposable bone marrow aspiration kits to physicians who use the kits to perform the CaverStem procedure. It contracts with physicians to purchase kits, and in turn, provide exclusivity in their market through its patent protection, marketing support, and training.
The company's CaverStem technology is protected by U.S. Patent No. 8,372,797, entitled 'Treatment of Erectile Dysfunction by Stem Cell Therapy', which was issued to CMH by the United States Patent and Trademark Office (USPTO) on February 12, 2013. The company acquired this patent and related know-how and technology from CMH in May 2016. CaverStem is also a U.S. registered trademark (Reg. No. 5716528).
In August 2017, the company completed recruitment on a clinical trial of the CaverStem procedure conducted by the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center. Following completion of recruitment and treatment of the study subjects, an independent Institutional Review Board (IRB) overseeing the study validated the procedure as safe. The CaverStem procedure is both safe and effective and commenced marketing activities in November of 2017. From November 2017, through September 2020, the data from 40 patients in the clinical trial was combined with data from a 100-patient clinical registry and analyzed. The results were then submitted to the Journal of Translational Medicine for peer-review and publication and subsequently published in its January 2020 edition. The peer-reviewed results validated 100% safety and 85% efficacy of the CaverStem procedure. This marked the largest ever study of the safety and efficacy of bone marrow stem cells used to treat erectile dysfunction.
FemCelz - Female Sexual Function Treatment
In September 2018, the company launched its proprietary FemCelz procedure for the treatment of the loss of genital sensitivity and dryness experienced by women. The FemCelz procedure uses the patient's own stem cells to improve female sexual function, and is similar to the CaverStem procedure. FemCelz is exempt from the FDA premarket review and approval process under Section 361 of the Public Health Service Act (PHS Act), as the procedure involves the autologous treatment of a patient with her own cells during the same surgical procedure without intervening processing steps.
The company's FemCelz stem cell treatment consists of a one-hour out-patient visit in a physician's office. The physician harvests a patient's stem cells from bone marrow in the hip using a local anesthetic. The extraction device is designed to harvest only the stem cells, while filtering out the red blood cells, thereby eliminating the need for any centrifugation. The cells are then injected into the pubocervical fascia (peri-G-spot), skene's glands, and around the peri-clitoral to stimulate muscle and blood vessel regeneration.
The company generates revenues through the sale of disposable bone marrow aspiration kits to physicians who use the kits to perform the FemCelz procedure. It contracts with physicians to purchase kits and, in turn, provide exclusivity in their market through its patent protection, marketing support, and training.
FemCelz is a U.S. registered trademark (Reg. No. 6107881).
StemSpine - Regenerative Stem Cell Procedure for the Treatment of Degenerative Disc Disease (Clinical Trials)
The company's StemSpine procedure uses the patient's own stem cells to reverse the effects of atherosclerosis and treat chronic lower back pain.
StemSpine is exempt from the FDA premarket review and approval process under Section 361 of the PHS Act, as the procedure involves the autologous treatment of a patient with his or her own cells during the same surgical procedure without intervening processing steps.
The company's StemSpine stem cell treatment consists of a one-hour out-patient visit in a physician's office. The physician harvests a patient's stem cells from bone marrow in the hip using a local anesthetic. The extraction device is designed to harvest only the stem cells, while filtering out the red blood cells, thereby eliminating the need for any centrifugation. The cells are then administered into muscles surrounding the area of lower back pain, such as the psoas major muscle to stimulate blood vessel regeneration. New blood vessels increase circulation around the disc and thus stimulates regeneration of the disc.
The company's StemSpine technology utilizes biologicals to stimulate a process termed angiogenesis, which overcomes the deficient circulation causing disc degeneration.
In May 2017, the company formed StemSpine, LLC for the purpose of using stem cells to treat back pain under a patent it acquired from Creative Medical Health, Inc. (CMH). In June 2017, the company filed an additional patent application covering the synergy between intradiscal stem cell injection subsequent to stimulation of perispinal angiogenesis.
In October 2019, the company announced the successful completion of a pilot study of 15 patients with over 12 months of data showing safety and efficacy. Evaluation of patients at 30, 60 90, 180, and 360 days revealed significant improvement in mobility and reduction in pain score.
On February 14, 2023, the company announced positive three-year follow-up data for its StemSpine pilot study. The three-year data demonstrate continued efficacy of the StemSpine procedure for treating chronic lower back pain without any serious adverse effects reported. There were no safety related concerns at up to three years, and the StemSpine procedure resulted in a continued efficacy rate of 87% of patients that participated in the pilot study. No patients required re-dosage or surgical intervention since the last follow-up at two years.
StemSpine is a U.S. registered trademark (Reg. No. 5997521).
ImmCelz - Personalized Supercharged Immune Therapy (Pre-Clinical Trials)
The company is developing its ImmCelz technology for the treatment of multiple indications.
ImmCelz utilizes a patient's own extracted immune cells that are then 'reprogrammed' by culturing them outside the patient's body with optimized secreted factors. The immune cells are then re-injected into the patient from whom they were extracted. In contrast with other stem cell-based approaches, the immune cells are significantly smaller in size than stem cells and are believed to more effectively penetrate areas of the damaged tissues and induce regeneration.
Unlike its CaverStem, FemCelz, and StemSpine procedures, because the patient's cells are reprogrammed/supercharged prior to reinjection, the company will require FDA approval before it can market or sell ImmCelz.
The company developed ImmCelz initially using co-culture techniques which have now been advanced to a cell-free culture system. It has also utilized certain cell-free factors pursuant to a license agreement it entered into with Jadi Cell LLC, which is owned and controlled by Dr. Patel. The company has been granted the right to exploit Jadi Cell's patent rights (including the U.S. Patent Number 9,803,176 and similar patents issued by other countries) and proprietary know how in connection with the enhancement of autologous cells. However, based on the company's development of the ImmCelz platform, it has engineered the next generation of cell-free secreted factors, which are independent of the Jadi Cell LLC license. The company continues to have the previously licensed platform from Jadi Cells LLC for the first generation ImmCelz.
The company has filed an application with the USPTO to trademark ImmCelz (Ser. No. 88829362).
OvaStem - Stem Cell Therapy for Premature Ovarian Failure
The company is developing its OvaStem technology for the treatment of female infertility. Its treatment is intended to treat women suffering from infertility induced by factors, such as chemotherapy and other non-natural causes, as well as age-associated infertility, and infertility with unexplained causes. In these cases, IVF treatment may not be appropriate as the woman's ovaries are not able to generate eggs capable of being fertilized. The company's OvaStem procedure may be a suitable treatment for these women with damaged ovaries.
The OvaStem stem cell treatment will consist of a one-hour out-patient visit in a physician's office. The physician will harvest a patient's stem cells from bone marrow in the hip using a local anesthetic. The extraction device will harvest only the stem cells, while filtering out the red blood cells, thereby eliminating the need for any centrifugation. The cells would then be administered into the dysfunctional ovaries.
Like the company's CaverStem and FemCelz procedures, because OvaStem will utilize a patient's own extracted immune cells, management has determined that OvaStem will be exempt from the FDA premarket review and approval process under Section 361 of the PHS Act, as the procedure involves the autologous treatment of a patient with her own cells during the same surgical procedure without intervening processing steps.
On July 28, 2022, the company announced positive three-year follow up data for its OvaStem pilot study. The data shows significant efficacy of the OvaStem procedure for the treatment of medical refractory Primary Ovarian Insufficiency (POI) without any serious adverse effects and the successful birth of healthy babies.
Other Products and Services
Additional Indications
The company is also exploring the use of its technologies and/or has filed patents covering treatments for preventing the rejection of transplanted organs; kidney failure; liver failure; type 1 diabetes; heart attack; and Parkinson's Disease.
Marketing
The company markets its CaverStem and FemCelz procedures using a multifaceted marketing approach that includes a robust web site for each of these products (CaverStem.com and FemCelz.com) designed to attract and educate both physicians and patients; publishing results of clinical studies demonstrating the efficacy of its products and therapies, and building clinical registries accessible to medical professionals that include the results of such studies; online advertising; social media - Twitter, Facebook; in-office flyers and banners; patient testimonials; and informative videos.
The first product the company marketed was the CaverStem procedure to treat erectile dysfunction, which was initiated in November 2017. It subsequently initiated marketing of FemCelz in March 2020. The two procedures are offered in the following eight markets, including Arkansas - Martinsburg; California comprising Roseville and San Francisco; Florida - Orlando; Ohio - Dublin; Texas comprising Austin and San Antonio; and West Virginia - Fayetteville.
As of December 31, 2022, the company had recruited physicians by partnering with independent sales representatives who represent it to physicians across the United States and Europe. Going forward, the company plans to continue to partner with independent sales representatives.
Intellectual Property
The company's patent portfolio is composed of four issued patents and ten pending patent applications filed in the United States with the USPTO.
Patent Purchase and License Agreements
Lower Back Pain Patent Purchase: The company acquired the U.S. Patent No. 9,598,673 covering the use of various stem cells for the treatment of lower back pain from its affiliate CMH pursuant to a Patent Purchase Agreement dated May 17, 2017, which was amended in November 2017.
ImmCelz License: On December 28, 2020, the company entered into a patent license agreement with Jadi Cell, LLC. The agreement provides the company with an exclusive, worldwide license to the U.S. Patent No. 9,803,176 'Methods and compositions for the clinical derivation of an allogenic cell and therapeutic uses' and the proprietary process of expanding the master cell bank of Jadi Cell LLC, in the field of enhancing autologous cells.
Trademarks
The company has obtained trademark registration for CaverStem, StemSpine, and FemCelz; and has trademark applications pending for ImmCelz, OvaStem, iPScelz, AlloStem, and Alova.
Research and Development
The company's research and development expenses totaled $6,268,854 for the year ended December 31, 2022.
Government Regulation
In the event that the company's domestic United States operations are subject to the FDA's drug, biological product, or device regulations, it intends to comply with the applicable Current Good Manufacturing Practices and quality regulations.
