Cytori Therapeutics Inc (NASDAQ:CYTX) announced the publication of the results from an investigator-initiated Phase I trial using Cytori Cell Therapy in patients with insufficient maxillary bone prior to dental implantation. The publication reported approximately 42% greater bone formation in maxillary sinus floor elevation (MSFE) procedures treated with cells in combination with scaffolds versus those that received scaffold alone.
The study, conducted by investigators from Departments of Orthopedic Surgery, Oral and Maxillofacial Surgery, and Oral Cell Biology of the VU University in Amsterdam, The Netherlands, enrolled 10 patients requiring dental implants but who had insufficient bone into which the implant could be inserted. The maxillary bone deficiency was treated with two different commonly-used, off-the-shelf bone calcium phosphate scaffolds that were used either alone or pre-loaded with Adipose-Derived Regenerative Cells (ADRCs) prepared using Cytori’s Celution™ System. In six patients, the patient served as their own control as one side of the mouth was treated with scaffold alone and the other side was treated with ADRC-supplemented grafts. Six months after treatment all patients underwent dental implant placement at which time a biopsy of the regenerated bone at the graft site was performed.
The trial results reported approximately 42% greater bone formation in grafts that were supplemented with ADRCs. Specifically, in patients who received both a control scaffold and a contralateral ADRC- supplemented scaffold, the ratio of bone volume to total graft volume as measured by micro computerized tomography (microCT) was 19.5% ± 3.8% in grafts supplemented with ADRCs versus 13.7% ± 4.4% for the control grafts (p = 0.03). A similar trend was seen by histologic assessment of biopsies. They also noted that all 10 patients were treated uneventfully, with no adverse effects reported or detected in a large set of safety parameters through =3 years of follow-up.
Regarding the findings, the authors stated: “A striking observation from the histomorphometric and micro-CT analyses was the active bone formation observed at the cranial side of the biopsies in 7 out of 10 of the selected bone biopsies taken from the study [ADRC-treated] side, but only in 1 case from the control side. To our knowledge, this phenomenon has never been described before and may be unique to the current set-up.”
The American Academy of Implant Dentistry reports that approximately 500,000 patients receive dental implant surgeries in the USA every year. A recent report estimated that the global market for dental implants is projected to reach $5.8 billion by 2022. Use of calcium phosphate scaffolds for bone repair and reconstruction is also common in orthopaedic surgery. (Original Source)
Shares of Cytori Therapeutics are up nearly 14% to $2.32 in pre-market trading. CYTX has a 1-year high of $7.94 and a 1-year low of $1.91. The stock’s 50-day moving average is $2.16 and its 200-day moving average is $2.86.
On the ratings front, Cytori has been the subject of a number of recent research reports. In a report issued on June 27, Maxim Group analyst Jason Kolbert reiterated a Buy rating on CYTX, with a price target of $5, which represents a potential upside of 144.5% from where the stock is currently trading. Separately, on the same day, Roth Capital’s Joseph Pantginis maintained a Buy rating on the stock and has a price target of $11.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jason Kolbert and Joseph Pantginis have a total average return of -15.6% and 7.9% respectively. Kolbert has a success rate of 30.8% and is ranked #3976 out of 4064 analysts, while Pantginis has a success rate of 37.6% and is ranked #293.
Cytori Therapeutics, Inc. is a late stage cell therapy company. Its develops autologous cell therapies from adipose tissue, using its proprietary technology, to treat a variety of medical conditions. Data from preclinical studies and clinical trials suggest that Cytori Cell Therapy acts principally by improving blood flow, modulating the immune system, and facilitating wound repair.