Injectable Soft Tissue Augmentation or "Bulking" refers to medical procedures that selectively increase soft tissue volume at specific injection sites. Increase in tissue volume cannot only correct facial wrinkles and scars as accomplished with commonly used dermal fillers, but may also increase the 'resting pressure' in muscular sphincters throughout the human body by creating a 'mucosal plug' to re-establish the physiologic sphincter function and valve mechanism.
In addition, in the degenerated spinal disc, an ideal bulking agent may restore disc height and physiologic shock-absorbing and spinal motion properties after injection into the nucleus pulposus at the center of the disc.
During the past decades, various permanent injectable materials were tested as bulking agents to treat medical conditions such as GERD, Urinary Incontinence or Facial Wrinkles. No permanent materials to date have proven to be safe and effective with the exception of injectable PMMA microspheres suspended in bovine collagen, which received U.S. FDA approval for the treatment of naso-labial folds (smile lines) in 2006 (ArteFill®).
AscentX Medical believes that medical conditions affecting the growing aging population and that are related to sphincter muscle incompetence, spinal disc degeneration, or diminishing skin thickness, can be effectively treated with an ideal permanent injectable bulking agent by curing the underlying cause of those conditions, a ‘loss of tissue volume’. Related medical indications include severe chronic heartburn (Gastro-Esophageal Reflux Disease or GERD), Degenerative Spinal Disc Disease (DDD), Facial Wrinkles & Scars, Stress Urinary Incontinence (SUI), and Fecal Incontinence (FI).
In order to address these conditions, AscentX Medical has developed a unique 'permanent' bulking agent platform technology, which will remain safely and permanently at the injection site promoting formation of the patients’ own collagen around a matrix of polymeric microspheres:
After approximately one month of internal 'soft tissue remodeling', the newly created soft tissue bulk consists of 80% of the patient's own fibro-vascular tissue, and 20% synthetic microspheres (by volume).
Based on our pre-clinical studies1,2 for GERD and SUI, we believe our products meet the characteristics of an 'ideal injectable implant' material for soft tissue ‘bulking’ as defined below (adapted from Rupp T, Lehman G: Endoscopic anti-reflux techniques. Gastrointest Endosc Clin N Am 1994; pp 353-68):
- Biologically inert at implant site (non-carcinogenic, non-immunogenic)
- Precise, submucosal delivery
- Low side effect profile
- Easily removable without permanent tissue damage
- Non-biodegradable (permanent)
- Low viscosity (easy to inject through a 23-gauge needle)
- High persistence at implantation site
- Capable of resisting mechanical strain
- Favorable elasticity
- Favorable plasticity
- No adverse effect on adjacent musculature
AscentX Medical's technology platform consists of injectable microspheres made of polymethyl- methacrylate (PMMA), which are evenly suspended in a specifically designed bovine collagen carrier and provided in pre-filled syringes.
PMMA is a transparent thermoplastic first polymerized in Germany in 1877 by German chemists Fittig and Paul. The first PMMA materials were developed in Germany in 1928 and commercialized in 1933. Since then, PMMA has been used safely for almost 80 years in various implanted medical devices, including but not limited to intraocular lenses (ophthalmology), pacemakers (cardiology), bone cement (orthopedic surgery), and artificial dentures (dentistry).(23) PMMA is one of the most biocompatible (tissue-friendly) biomaterials known to date and does not illicit an inflammatory or foreign body reaction after implantation, as long as it meets specific physical and chemical characteristics and strict quality requirements.
After more than 25 years of PMMA use in the form of tiny microspheres suspended in collagen to correct facial wrinkles and scars (6-9), as well as the experience and expertise gained during an arduous FDA approval process for injectable wrinkle filler ArteFill® between 1999-2006, the core AscentX team decided to expand the use of injectable PMMA microspheres to other prevalent medical conditions affecting the growing aging population. We believe these conditions are curable via injectable soft tissue augmentation. Such indications include Gastro-Esophageal Reflux Disease (GERD), Degenerative Spinal Disc Disease (DDD), Facial Wrinkles and Scars, Stress Urinary Incontinence (SUI) and Fecal Incontinence (FI).
After the injection of PMMA microspheres into soft tissue structures, each individual microsphere serves as a stimulant and scaffold for autologous (patient’s own) collagen deposition and encapsulation. Within the first month, the bovine collagen carrier creates most of the tissue bulk until microsphere encapsulation and soft tissue remodeling processes take over. Within 4-6 weeks after injection, approximately 80% of the newly formed soft tissue 'bulk' consists of the patient’s own fibro-vascular tissue (autologous tissue formation) and 20% PMMA microspheres (by volume)(7).
Our research and development efforts since inception of the Company in 2008 have partly focused on progressive improvement of PMMA microsphere quality, as well as the collagen carrier material, in which they are suspended for injection. In this regard, we have developed new and proprietary manufacturing processes to produce both our microspheres and collagen to the highest quality standards as set forth by the U.S. Food and Drug Administration (FDA).
A narrow size distribution and overall microsphere conformity in regards to roundness, smoothness and shape are of critical importance to reduce the risk of adverse effects such as foreign body reactions.(24) In order to minimize or eliminate any potential side effects, it has been our goal to meet or exceed FDA’s stringent quality requirements in all our products.
Quality Evolution of PMMA Microspheres:
Worldwide ex-U.S. (CE-mark)
U.S. FDA Approval of ArteFill®
< 1% of PMMA "by the number" is <20 microns
2016 - U.S.
2016 - U.S.
We strive to incorporate the highest quality bovine collagen sourced from a U.S.-based, virally and genetically 'closed' cattle herd, in all of our products to ensure maximum patient safety. Even PMMA microsphere suspension throughout the syringe at room temperature, as well as even microsphere distribution at body temperature after injection, are essential requirements to achieve superior augmentation results.
AscentX Medical exclusively licensed U.S. Patent # 8,586,089 (issued November 2013) and pending international patents for the treatment of Gastro-esophageal Reflux Disease (GERD), Facial Wrinkle and Scars, and Degenerative Disc Disease (DDD).
The Company also developed proprietary injection devices used in conjunction with standard endoscopes to precisely deliver its scientifically formulated bulking agents into the submucosal space of targeted soft tissue structures.