Yesterday judge ruled that MDXG and OSIR will go to jury trial in the spring. My question - Is MDXG going to court to publicly prove Grafix is better? Im not an attorney but my defense would be, lets read the study (or at least an entire sentence). This is all online in the Pacer system thanks to MDXG. -- MDXG Court filing states, “35. The Study does not state that the unclosed wounds treated with EpiFix® demonstrated clinical deterioration. Rather, the Study states that “there was no clinical improvement” in the unclosed EpiFix®-treated wounds within the defined timeframe. The Press Release’s statement therefore falsely implies that treatment with EpiFix® caused the wounds to deteriorate, which is not supported by the underlying Study.” Here is what the study states, “In contrast, there was no clinical improvement observed in the non-closed dHACM population (n = 45) based on an overall increase in wound dimensions after management with dHACM.” -- MDXG Claim, “37. The Study does not show that Grafix® demonstrated superior outcomes to EpiFix®. Rather, the Study shows that EpiFix® closed the same number of, if not more, diabetic foot ulcer, arterial ulcer and pressure ulcer wounds by the end of treatment as the Grafix® product.” The study states, “When compared, vCPM demonstrated clinical effectiveness, as evidenced through a significantly higher closure rate (63.0% vs. 18.2%) in much larger wounds (9.4 cm2 vs. 2.1 cm2) compared to dHACM.” -- MDXG claim, “38. Additionally, the Study shows that, on average, patients receiving treatment with Grafix® received at least 1.5x to 2x the number of graft applications than those patients receiving treatment with EpiFix® and that EpiFix® worked more quickly than Grafix® (an average treatment duration of 28.5 days for EpiFix® compared to 50 days for Grafix®) for closed wounds. Therefore, for certain types of wounds, EpiFix® was able to close the wound more quickly and with fewer applications than the Grafix® product.” The study states, “The difference in the number of graft applications and treatment durations for vCPM correlated with the statistically larger size of wounds closed in this group (p = 0.0201).”
Looking forward to a fresh start under new CEO, financials in order, product developments and updates! We've certainly earned it!
Osiris should be back on track soon. While Osiris never talked a lot to the Street (Swiss influence?), I assume the current lack of communications comes from their legal counsel as they prepare to produce financials. Yet with some basic due diligence, we can understand some key elements of what they are not publicly discussing. For example, we know Osiris received $10M from Mesoblast last month. We see federal purchases of all products, at a health pace vs MDXG. We also see lots of hiring with emphasis on sales and also surgical sales (Stravix), indicators suggest overall growth in headcount. We see Osiris personnel at conferences. We see publications on product efficacy. Research continues to make progress. Mesoblast makes progress with Osiris Prochymal. They may have $1 in cash per share and no debt. Difficult to imagine how sales wouldn’t expand given the significant increase in insurance coverage. Lastly, a recent court document confirms the March press release to complete the audit in September – a timeline which gives a new CEO and CFO time to acclimate. Yet we have our majority shareholder Peter, board members, and other key players with significant holdings. Yet we don’t observe them selling. There are things to wonder about. How fast can Osiris grow revenue for Grafix, Stravix, Cartiform, and Bio4? What can the new Prestige Lyoprocessing tissue-based products and processing mean for sales or licensing opportunities? What is Osiris doing in partnership with PCT Cell Therapy (research or production)?
Has $OSIR contracted with AZIYO to manufacture BIO4 & Cartiform?
Completion of Form FDA 3356 is required for establishments engaged in the recovery, processing, storage, labeling, packaging, or distribution of HCT/P, or the screening testing of tissue donor….Item 14. PROPRIETARY NAMES - Indicate any applicable proprietary names used for the HCT/Ps listed, such as a trademark.
On AZIYO’s form, under Item 14, Additional Information:
Proprietary Name(s): a. Bone – Private Label HCT/Ps Osiris Therapeutic, Inc: BIO4
b. Cartilage – Private Label HCT/Ps Osiris Therapeutics, Inc: Cartiform
This long wait with the hope that positive things will come is wearing me out. Two years is a long time. Any negative press release at this point might spell disaster. I hope we hear some good news soon. If so maybe a slight bump in pps? Good luck to all longs out there.
Just as I thought John Boy, your pictures were mainly of dime size DFU's with just a few quarter sizes. My statement still stands, "no way can Epifix heal [facilitate, ha] large exposed tendon and bone wounds".
by ozark580 • Jul 22, 2015 10:23 PM
We may flush out some the new Shorts tomorrow. I figure we picked up about 150,000 shorts at $23.67 and about 200,000 more at $22.80. Some covered at the $19 level, but I'd bet there are a few more still hanging around.
They may try to hold-the-line in the early morning hours, but it just may be too hot to them to handle. Osiris has the juice right now.
Here are the two Stravix brochures I spoke of earlier. If you are squeamish about seeing open wounds then it's best not to look at these links. Stravix to the rescue. There is no way Epifix could heal wounds like these.
MDXG has a $1.75B market cap with 2016 revenues of $245M, this is a 7.14 multiple. If OSIR had $115M of revenue in 2016 (per OSIR press release), market cap could be $821M ($23.81 pps). Of course the market is waiting on financials.
Stravix seems to be a product needed in every operation theatre every day. Potentially it has bigger market than Grafix. Cartiform may have same possibilities.
Journal of orthopaedic surgery and research June 12, 2017 Open surgical implantation of a viable cryopreserved placental membrane after decompression and neurolysis of common peroneal nerve: a case series.
Rodriguez-Collazo E1, Tamire Y2. Author information 1 Chicago Foot & Ankle Deformity Corrections Center, Department of Surgery Adults & Pediatric Ilizarov Correction, Microsurgical Limb Reconstruction, Presence Saint Joseph Hospital, Chicago, Illinois, USA. 2 Medical Science Liaison, Osiris Therapeutics, Inc., 7015 Albert Einstein Drive, Columbia, MD, 21046, USA. firstname.lastname@example.org. Abstract BACKGROUND: The purpose of this study is to report on the rehabilitative outcomes associated with common peroneal nerve (CPN) decompression and neurolysis revision when performed with open surgical implantation of a viable cryopreserved placental membrane (vCPM). METHODS: Seven patients who underwent secondary CPN decompression and neurolysis with open surgical implantation of a viable cryopreserved placental membrane (vCPM) after previously failed surgery without vCPM utilization were identified through a retrospective medical record review and outcomes were analyzed. Primary mechanism of injury, severity of symptoms at time of referral, pre-operative and post-operative evaluations on edema with ultrasound, Medical Research Council (MRC) scale for motor strength, range of motion, nerve conduction velocity (NCV), and electromyography (EMG) were analyzed. RESULTS: Five patients (71.4%) achieved full recovery of motor function MRC grade 5/5, and the remaining two patients achieved MRC grade 4/5. At the 7-month follow-up visit, NCV tests indicated improved conduction velocity and normal amplitude for all 7 patients, and all patients demonstrated proper gait pattern with a return to normal activities of daily living. There were no vCPM-related adverse events. CONCLUSIONS: The use of vCPM wrap as an adjunct to surgical repairs of CPN injuries may contribute to positive clinical outcomes.
Summer 2017 in USA began June 20 and ends September 22. OSIR new CEO has one month to publish finance for 2015-16 and fulfill the promise to make it during summer 2017. Well, let's wait one more month. If she continue keep silence even after Sep 22 OSIR investors will say: "Osiris Therapeutics names new CEO — unfortunately again stupid one". Fourth since February 2016 and all are idiots? It's unbelievable. Who hired them? May be all members of OSIR Board of Directors already senile? I hope I'm not right and we will see some update before end of summer.
8/14/17 - "Based on these results, a cost effectiveness study estimated that Grafix saves approximately $14,000 per patient"
-"Almost all patients (96.3%) developed granulated tissue in their wound bed (a precursor to wound closure) and 59.3% closed their wounds."
Arthrex just sold $25,500 worth of Cartiform to the VA on August 2, 2017. So far this year Arthrex has sold $356,597 worth of Cartiform in 2017 with the Veterans Administration (VA). Nice little piece of business. Some here have said the the VA business is only 1% of the total business...
Osiris making a good showing at the East Podiatric Residency Summit this weekend.
Stravix® cryopreserved placental tissue, composed of the umbilical amnion and Wharton’s Jelly, retains the extracellular matrix, growth factors, and endogenous neonatal mesenchymal stem cells, fibroblasts and epithelial cells of the native tissue.
COLUMBIA, Md, August 18, 2017 - Osiris Therapeutics, Inc., a leading regenerative medicine company focused on developing and marketing products for wound care, orthopedics, and sports medicine, announced that they hoped to release 2015 financial statements by the end of this decade with 2016 statements to be released shortly thereafter.