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Biotech / Medical SRDX - SurModics - Biotech IPO

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To: Will Preska who started this subject	12/15/2003 3:15:41 AM
From: Lance Bredvold	of 83

Oct2002 review panel of the cypher sirolimus stent questions and discussion was offered by foolishpremise on Yahoo. I tried to bring the message over here, but the second URL would not transfer so let me simply refer to the Yahoo post and point out another offering by the same poster 4 messages later which lead one to 3 pubmed articles about more recent stent trials. The first I found most interesting as it described the condition of a 71 year old woman who had died afer implantation of uncoated stents on her right side, later implantation of sirolimus coated stents on the other side. finance.messages.yahoo.com Edit; I don't get it. The entire URL shows on my edit form but does not print on the published version. Yet it seems to get me where I want to go. Anyway, the two Yahoo posts I am recommending are 7988 and 7992.

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To: Lance Bredvold who wrote (51)	12/17/2003 9:26:04 AM
From: cooksbay95	of 83

Lance, Just wanted to say thx for posting ... your objective of just showing key info was perfect for me to get up to speed ... and as you suggested valuable before entering the Yahoo babble boards.

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To: Will Preska who started this subject	1/4/2004 11:25:21 AM
From: Lance Bredvold	of 83

Patent search: This effort becoming a compendium of helpful posts by foolishpremise. Thank you for your appreciation. Better posted here than allowing such information to be buried and I can no longer remember it all. I don't understand why, but the first URL seems to work even though it looks incomplete. It actually gets me to SRDX patents issued. The second one is missing some features but will at least get one to the Patent Office site. L. Re: SRDX awarded 5 new patents... by: foolishpremise (38/M/Vancouver, BC) 01/03/04 12:25 am Msg: 8258 of 8267 patft.uspto.gov MBA: You've fallen into an easy mistake with this search engine. Your search returns all patents with the word Surmodics in any field (including the description of the device). Many of the patents listed appear simply because they use Surmodics stabilizers, or state that they could add coatings "such as offered by Surmodics". Many (most) of them are not Surmodics patents. To get a better picture of Surmodics patents you need to limit your search to the Assignee field. patft.uspto.gov tml%2Fsearch-adv.htm&r=0&f=S&l=50&d=PTXT&Query=AN%2Fsurmodics

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To: Will Preska who started this subject	1/9/2004 12:47:48 AM
From: Lance Bredvold	of 83

NitroMed nitric oxide PR for stents by: skiplarson98 (55/M/Montana) 01/08/04 12:53 pm Msg: 8327 of 8334 Press Release Source: NitroMed, Inc. Boston Scientific and NitroMed Extend Collaboration on the Development of Nitric Oxide Coated Stents Thursday January 8, 8:14 am ET Companies Extend Development Agreement for Two Years BEDFORD, Mass.--(BUSINESS WIRE)--Jan. 8, 2004--NitroMed, Inc. (NASDAQ:NTMD - News) today announced the extension of an exclusive worldwide research collaboration, licensing and commercialization agreement with Boston Scientific Corporation (NYSE: BSX - News), for the development of nitric oxide coated stents to complement Boston Scientific's Paclitaxel coated stent. Under the agreement the companies will continue to seek to develop and advance nitric oxide releasing compounds that can be incorporated onto stents to treat a variety of vascular diseases. The contract extension continues the research and development collaboration through 2005 and includes an upfront payment of $3 million to NitroMed. The extension builds on the original agreement executed in 2001 and includes milestone payments in the event specified research, development and commercialization milestones are achieved, as well as royalties on any product sales. Prior to the extension NitroMed received a total of $1.5 million in research and development funding and $4.0 million in equity investments from Boston Scientific. ADVERTISEMENT "Boston Scientific has been a great ally and we are pleased to extend our agreement," said Michael D. Loberg, Ph.D., President and CEO of NitroMed. "We view this as an important validation of our expertise in nitric oxide-enhancing medicines and highlights our strengths in the development of proprietary new classes of drugs. We believe Boston Scientific, a worldwide leader in medical devices, is well positioned to bring our proprietary nitric oxide-releasing compounds to market in a novel application." NitroMed has demonstrated in a variety of pre-clinical studies that its proprietary stents coated with a nitric oxide donor can significantly reduce restenosis, which is a narrowing or blockage of the artery that occurs after a procedure such as a balloon angioplasty or a stent placement. This narrowing is primarily caused by an exuberant proliferation of cells, which can eventually block the artery and the blood flow. Nitric oxide is a critical component of the artery and is endogenously produced by the endothelium. It has been shown to play a critical role in vascular stasis as well as inhibiting vascular smooth muscle proliferation, platelet adhesion and aggregation, and local inflammation. About NitroMed NitroMed is an emerging pharmaceutical company that discovers, develops and seeks to commercialize proprietary pharmaceuticals based on the therapeutic benefits of the naturally occurring molecule nitric oxide. The Company uses its expertise in nitric oxide biology and chemistry in an effort to develop both novel drugs, as well as safer, more effective versions of existing drugs. Research and development efforts focus on major diseases that are characterized by a deficiency in nitric oxide, such as cardiovascular and inflammatory diseases. BiDil®, the Company's lead product in development, is an orally administered nitric oxide-enhancing medicine being investigated for the treatment of heart failure in African Americans. A late-stage confirmatory trial targeted to enroll 1,100 patients is underway in more than 160 sites throughout the United States. The Association of Black Cardiologists is a joint sponsor of the study. Collaborative partnerships are a key element of the Company's business strategy. NitroMed has agreements with Merck to jointly develop nitric oxide-based COX-2 inhibitors and with Boston Scientific to jointly develop nitric oxide coated cardiovascular stents. For additional information about NitroMed, please consult the Company's website at www.nitromed.com. Safe Harbor for NitroMed, Inc...."

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To: Will Preska who started this subject	1/10/2004 2:24:41 AM
From: Lance Bredvold	of 83

Article by Aron Anderson on intravitreal drug delivery. From Sept 1. Thanks to Chip_Blockus on Yahoo for finding and delivering it. medicaldevicesonline.com D=2 Combining Local Drug Delivery and Implantable Medical Devices September 1, 2003 By: Aron B. Anderson Medical Device Technology Pages \| 1 \| 2 Figure 3: Example of in vitro drug release from drug-eluting coatings for the intravitreal drug delivery device. This experiment shows that drug elution control and extended release duration can be achieved for months to years by varying the polymer matrix composition. Intravitreal implant drug delivery Diseases of the eye are a particularly good opportunity for local delivery of a drug. Several of the most serious diseases that threaten vision, including age-related macular degeneration, diabetic retinopathy, macular aedema, choroidal neovascularisation and uveitis, cause injury to the retina, the light-sensing tissue at the back of the eye. It is difficult, however, to deliver drugs via blood circulation to the back of the eye because of the blood-retinal barrier. It is also not practical to deliver drugs to the retina from the external surface of the eye, because of diffusional barriers that exist in the tissues at the front of the eye. Consequently, local delivery of a drug to the internal chamber of the eye is perceived to be the most effective route. Apart from injection using a needle, there are no standard methods of delivering drugs to the internal (vitreous) chamber of the eye. Furthermore, there are limited currently approved methods of providing long-term delivery of a pharmaceutical to the interior of the eye. The same drug delivery matrix technology developed for stents is being used for application on the surface of an ophthalmic drug delivery implant.6 The implant can be inserted into the eye, left in place until the drug has eluted from the delivery matrix, and then retrieved. If further therapy is needed, another implant can be placed at the site; this process can be continued until the therapy is complete. Elution experiments run on the coated devices showed that a high level of drug loading and a wide range of in vitro release rates can be achieved by modification and fine-tuning of the coating formulations (Figure 3). This drug delivery/device combination is currently in preclinical testing. Table II: The advantages of combining controlled local drug delivery with an implantable medical device over systemic delivery of a drug. Conclusion Implantable medical devices have limitations in terms of their efficacy or useful lifetime because of the inherent response of the body or pathogens to implants. The methodology of combining controlled local drug delivery with an implantable medical device offers several advantages over systemic delivery of a drug (see Table II). With the recent proven success of drug-eluting stents in interventional cardiology, the local drug delivery/device combination therapy is becoming an exciting new frontier in medicine with vast social and economic potential. The drug is targeted to the intended site of action, ensuring that the tissue needing the drug receives it There is no need to use high or toxic systemic doses to achieve sufficient local concentrations A sustained, controlled dosing level can be maintained around the device over the necessary duration. References 1. R.S. Hill et al., "Immunoisolation of adult porcine islets for the treatment of diabetes mellitus. The use of photopolymerizable polyethylene glycol in the conformal coating of mass-isolated porcine islets," Ann. N. Y. Acad. Sci., 831, pp. 332−343 (1997). 2. W. Casscells, "Migration of Smooth Muscle and Endothelial Cells. Critical Events in Restenosis," Circulation, 86, pp. 723-729 (1992). 3. T. Suzuki et al., "Stent-Based Delivery of Sirolimus Reduces Neointimal Formation in a Porcine Coronary Model," Circulation, 104, pp. 1188−1193 (2001). 4. J.E. Sousa et al., "Sustained Suppression of Neointimal Proliferation by Sirolimus-Eluting Stents: One-year Angiographic and Intravascular Ultrasound Follow-Up," Circulation, 104, pp. 2007−2011 (2001). 5. M.C. Morice et al., "A Randomised Comparison of a Sirolimus-Eluting Stent With a Standard Stent for Coronary Revascularisation,"N. Engl. J. Med., 346, pp. 1773−1780 (2002). 6. S. Varner et al., "Design of a Minimally Invasive Intravitreal Drug Delivery Implant," Association for Research in Vision and Ophthalmology Annual Meeting, Fort Lauderdale, Florida, USA, May 2003. Aron B. Anderson SurModics Inc. Eden Prairie, Minnesota, USA

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To: Will Preska who started this subject	1/22/2004 11:18:41 AM
From: Lance Bredvold	of 83

New imaging agent for Alzheimers licensed to Amersham/GE. Last evening earnings came out at $.23 and revenues at $12.1mm followed by much complaining about how much management should be telling analysts and us. I found the results predictable if a bit on the low side and worked out some numbers which suggest about 300,000 procedures were done during the quarter in the US, half with Cypher and half otherwise. JNJ said 76 percent of all stent money was spent on Cyphers and that cypher dollar (could be units) sales had increased 10% quarter over quarter. At any rate, it looks to me like SRDX is gaining about a penny per share after taxes for each 10,000 cyphers JNJ sells and I expect they will sell an additional $50mm in our second quarter to Mar. 31 bringing their total world unit sales to about 200,000 stent sales in the US vs about 180,000 in the first quarter. I should go back and read the responses to my posts on those numbers on Yahoo in the middle of last night to see if someone picked up some glaring mistakes--have not done it yet. My numbers are not solid and depend upon how accurate JNJ's estimates were, but they give me a feel for the total numbers of units and procedures being done each quarter. Sales in ROW seem to run about 40,000 stents a quarter when I guess that JNJ gets an average of $2000 per stent overseas, but that is just a guess. They had $80mm of ROW sales last quarter and that was up significantly but mostly due to currency weakness of the dollar. "Reuters New imaging agent could help diagnose Alzheimer's Wednesday January 21, 5:51 pm ET WASHINGTON, Jan 21 (Reuters) - A new imaging agent that homes in on the gummy plaque believed to destroy the brains of Alzheimer's patients may finally allow the disease to be diagnosed before it kills, researchers said on Wednesday. The agent, a radioactive dye called Pittsburgh Compound B, can also be used to test new drugs being developed to fight Alzheimer's, which affects an estimated 4 million Americans, the researchers said. The hallmark of Alzheimer's is the buildup of protein clogs called amyloid beta. These eventually destroy the brain, robbing patients of their memory and eventually their ability to care for themselves. There is no cure for the disease. Using the new agent, "we will likely be able to follow the progression of the disease and speed the development of promising new therapies aimed at halting the build-up of amyloid in the brain," Dr. William Klunk of the University of Pittsburgh, who led the study, said in a statement. Writing in the Annals of Neurology, Klunk and colleagues said the imaging agent allowed the use of positron emission tomography, or PET, to view the plaque in the brains of 16 Alzheimer's patients. They also used the method on nine healthy volunteers. "We will not only find out when plaques begin to form, we will be able to see directly if a medication is preventing or reversing plaque formation over the long term," Klunk said. The Alzheimer's Association, which helped fund the study, said it was an important step forward. "We now have a tool to detect one of the hallmarks of Alzheimer's disease in the brains of living patients. Until now, this could only be shown at autopsy or by brain biopsy," said the Association's William Theis. Chet Mathis, a chemist and professor of radiology who worked on the study, said the imaging compound uses a dye that homes in on plaque, attached to a radioactive carbon "tag." The dye, an adjusted version of the dye used by pathologists to find Alzheimer's in brain samples from dead patients, is harmless, Mathis said. "In two hours it is gone from the body," he said in a telephone interview. He said the compound, patented by the university, had been licensed to Amersham (London:AHM.L - News), a British healthcare firm that makes imaging agents. General Electric (NYSE:GE - News) is about to take over Amersham."

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From: Lance Bredvold	11/14/2021 5:49:32 PM
	of 83

I've liked the way Gary Maharaj speaks, clearly and without exaggeration. The company has always made money but for the first time now, they've decided to breakout of the conservative pattern they've established and predict a loss for next year due to beginning to market their own products. Hired 8 sales people and predict huge market potential. And because they've always been so conservative in predictions, I believe them. Clearly it's disappointing that Surveil has been delayed, but management knew that when they decided to stop partnering products with the large pharma's and device companies and go it alone. Again, I am convinced they know what they are doing and would not try such a bold move without good reason. Still the market seems to be discouraged by the sudden predicted losses (and my own suspicion is that they decided once again not to count chickens before hatch so that any surprise is apt to be positive) and I'm anxious for the price to drop still more so I can buy more. I think my last purchase was on puts I'd sold for a $45 strike--yes, there it was at $45 less $7.10 put premium on 5/13/20. I might try that again now while so many seem discouraged. The question about cash position at yearend 2022 if ABT pays the possible milestone or if not, also was reassuring to me--no debt nor any need for more debt--and worst case, perhaps a borrowing from their $30mm line of credit--they did borrow $10 mm recently for the purchase of that company with a venous thrombectomy product named ReVene. Even that is a bold move for this management team and I'm confident was carefully thought out. I've sold a few at higher prices, bought at lower prices, but with no dividend and plenty of volatility, that is pretty much the only way I'm going to make money on SRDX--but it's an excellent investment none the less as long as I keep doing that. Best, L.

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From: Lance Bredvold	11/15/2021 9:45:11 AM
	of 83

I guess what this means is that SRDX is now more of a "story stock". No profits, but great hopes.

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From: Lance Bredvold	4/27/2022 10:48:11 AM
	of 83

Finally selling below $40 after today's earnings report. I had expected the decline much earlier, but somehow optimism in the market as a whole caused the price to stay up despite poor expected earnings on the modified strategy. I'm mostly bothered by failure to report higher income since the idea was to hire their first 4 hot shot salesmen and that they would begin to increase sales. Yes, sales are up to $26mm now which is several mm. better than either last year or last quarter. But they surely don't knock my socks off. The market has had a major rout and yesterday we were down to about 87% of the S&P500 high (4175/4819) with SRDX showing little consistent weakness. The potential for 2022 is a loss of about $14mm to a small gain if the ABT surveil DCB gets premarket approval. Gary may be trending toward a little more promotional stand as he must defend his decision to, for the first time, borrow significant funds on their revolving credit facility as the attempt to become a device selling company. Like last quarter, I would like to buy but at a price well below today's. I suppose we could back off the aggressive sales move and go back to being consistently profitable on in vitro and progress payments, but that is unlikely. So, until the new strategy is proven, I expect the stock price to be weak--in fact, to decline from it's current highs. But again, I've found Gary's reports to be factual and sound, his leadership decisions wise, and I'll gamble that SRDX will eventually pull off the strategy he has undertaken.

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To: Lance Bredvold who wrote (59)	4/27/2022 2:06:11 PM
From: Lance Bredvold	of 83

Wow. Did I just hear Gary say they have 19 sales professionals at the end of 2nd quarter? Why aren't device sales higher? OK! The answer seems to be the lag time from initial contact to actual decision by larger organizations. Up to 6 months when the first change to commercialization strategy was made in November, 21. It's very early and Gary/Tim sound very comfortable with results. I'm afraid I'm not going to get a much better price than the $39 plus we saw this morning before the call. I was really confused by Tim's presentation, but as usual Gary was clear with a couple of really nice subjective stories of success. Going back to sales people: 8 at the end of 21, 14-16 around February and 19 now! Well, no wonder we are seeing losses at the moment despite great success. I'm enthused as usual. Flying under the radar now, but just about to see competitors take notice. I am confident again and intend to place another order wishing I'd had one in earlier today. Just got 2 batches at $39.50 and hoping the headline news of large losses brings the price down still further.

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