Is this the start of the Australian Life Science Boom? The Viralytics/Merck deal is telling you something...
Just over eighteen months ago, in July 2016, I published an article headlined 'The Coming Boom in Life Sciences, Down Under' in which I suggested that Australia was on the way to a boom for its biotech and medical device sector. I argued that all the elements of that coming Boom were gradually falling into place. Comparing the present day with the investment climate of Australia in the-mid-to-late 1960s, I then gave the opinion that what was needed to kick off the Boom was Australian biotech's 'Kambalda Moment'. What I was referring to was the April 1966 nickel discovery at Kambalda in Western Australia that eventually resulted in the fabled Poseidon Boom three years later. I encourage you to check out my July 2016 article in the light of what I am arguing here - that Australian biotech has just had its Kambalda Moment in the second half of February 2018, and, if I'm right, the Boom is now set to pick up a significant head of steam. The Moment I'm describing is actually two events that happened last week. Firstly, the announcement on Wednesday 21 February that Merck & Co. will acquire the Sydney-based oncolytic virus developer Viralytics for US$394m, and secondly, the announcement the following day that the Melbourne-based regenerative medicine company Mesoblast had successfully achieved the primary endpoint in its Phase 3 study of remestemcel-L in Graft-versus-Host Disease. The fact that we had two 'sit up and take notice' events at the same time makes me particularly bullish about the prospects of the Australian Life Sciences sector. You can check out my latest thinking in today's article, which I've headlined 'It's 2018. Is this the start of the Australian Life Science Boom?'. Enjoy. It's even got a quote from the Bible.
Want a sure-fire way to make money in biotech and medical device stocks? There is none. There are, however, certain things you can do to maximise your chances of success. I have been arguing lately that one of the better ways to do that is by buying stock in companies where the CEO is a woman.
At NDF Research we recently analysed the global Life Sciences sector and found that only around 7.5% of CEOs in the sector were women. The sector in Australia and New Zealand does better, with a 13% female CEO rate, however that's still too low, in my opinion, because there are plenty of talented women working in the space that could be good CEOs if they got the tap on the shoulder.
Don't get me wrong. Stuart Roberts of NDF Research has not suddenly become a card-carrying feminist demanding CEO quotas for women. I've simply noticed that, since there are relatively few women in leadership in the Life Sciences sector, the women who do get to the top in their companies tend to be smarter and work harder than their male counterparts - because they know that gender equality isn't something you can take for granted, even in a more 'progressive' sector like Life Sciences. That provides investors with an opportunity. Buy a Life Sciences company with a female CEO and you're more likely to make money in the long run.
You can check out my thinking on gender inequality in the Life Sciences as an opportunity for investors at ndfresearch.com, where last month I published an article headlined Australia's growing support for women in Life Sciences. Its another good reason to look at this exciting industry where fortunes will be made in the years ahead as small cap companies mature into large caps and from there into blue chips.
I also urge you to check out the Life Sciences companies that are run by women such as Dimerix, AdAlta and Phylogica, all of which we cover at NDF Research.
Finally, here's an interview I recently performed for Health Invest TV with one of those talented female CEOs, Kathy Harrison of Dimerix, at the recent JP Morgan Life Sciences Week in San Francisco. See if you don't agree with me that Dimerix has a great story to tell - bit.ly/2mHDQow.
Today we've initiated coverage on Patrys (ASX: PAB), a Melbourne-based company that may have one of the world's first cell-penetrating antibodies for the treatment of cancer.
To understand the Patrys opportunity, you need to do two things at once. Think micro: recognising that Patrys has a world-first, cell-penetrating anti-DNA antibody. At the same time, think macro: recognising that its ground-breaking drug will play into a US$84bn antibody market. Taken together, these ingredients have the feel of blockbuster potential. The story started when Patrys in-licensed a ground-breaking antibody from Yale University in 2016. One way that cancer cells stay alive is by self-repairing their DNA when it breaks – and Yale’s Deoxymab 3E10 prevents this. Importantly, Patrys has now upgraded this antibody for human use. And, on the basis of its pre-clinical work, it recently announced that its version (PAT-DX1) may have application for a broad range of cancers: glioblastoma, colon cancer, triple negative breast cancer; and possibly, melanoma and other cancers as well. This product will enter the clinic in 2019. Back in 2014, AstraZeneca gained FDA approval for Lynparza, the first of the revolutionary PARP inhibitor drugs for the treatment of cancer. For reasons explored further in this note, Patrys’ product could be superior since it can prevent double-strand as well as single-strand cancer DNA repair. In addition, it can be synergistic with PARP inhibitors, and conjugated to other drugs of interest. This antibody is Patrys’ current priority – but the company still retains (for possible future attention) the IP from its original work on creating a new class of monoclonal antibody drug. We value Patrys at 7.3 cents per share base case and 18.3 cents optimistic case. Our target price of 13 cents per share sits at the midpoint of our valuation range. We see Patrys being re-rated by the progress into the clinic of PAT-DX1 and continued commercial success for the PARP inhibitors.
You can download a copy of NDF Research's initiation report on Patrys by clicking here or visiting ndfresearch.com. We commend the report to you. Note - the usual disclaimers apply - click here.
Today we've initiated coverage on Novogen (ASX: NRT), a Sydney-based cancer drug developer whose lead compound is GDC-0084, for the treatment of glioblastoma.
Glioblastoma is an acute brain cancer with, at the moment, limited treatment options. As such, there’s a billion-dollar market opportunity waiting to be realised. That is Novogen’s prime focus – and it commences a Phase 2 trial of its small-molecule GDC-0084 before year end. Back in 2016, notwithstanding positive Phase 1 results, Genentech offered this candidate for sale and Novogen was the successful bidder, attracted by the prospects for a successful inhibitor of the cellular signalling pathway PI3K. There are others chasing this pathway and in 2014 Gilead obtained approval for Zydelig. But unlike their drug, Novogen’s candidate is specifically focused on glioblastoma and has the advantage of a molecule that not only has an already-demonstrated Phase 1 safety record but, uniquely, has the ability to cross the blood-brain barrier. If Phase 2 is successful, there may be accelerated approval for GDC-0084 given the paucity of current glioblastoma treatments. In addition to GDC-0084, Novogen has an ovarian cancer drug (developed by Novogen) that completes Phase 1 in 2018. A proposed name change to Kazia Therapeutics reflects the new lead compound and the arrival of a highly-experienced management team, led by Dr James Garner. We value Novogen at 8 cents per share base case and 26 cents per share optimistic case. Our target price of 17 cents per share sits at the midpoint of our valuation range. We see Novogen being re-rated by the progress into the clinic of GDC-0084.
You can download a copy of NDF Research's initiation report on Novogen by clicking here or visiting ndfresearch.com. We commend the report to you. Note - the usual disclaimers apply - click here.
This week we've initiated coverage on SUDA (ASX: SUD), a Perth-based a drug delivery company focused on oral spray formulations of existing drugs.
Imagine these five things. First, a small pharmaceutical company with a unique platform for reformulating billion-dollar drugs for oral delivery. Second, that such delivery is not only safer but also much faster-acting. Third, that the target markets are large, including patients suffering migraine, anxiety, erectile dysfunction, nausea and malaria. Fourth, that a reformulated approval potentially involves months (not years) and costs a few (not hundreds of) millions. Fifth, that the small pharma already has its first licensing deal with a top-20 global pharma, as well as two other recent deals. Well, the small pharma is SUDA. We value it at 9 cents per share base case and 25 cents per share optimistic case using a probability-weighted DCF approach. Our target price of 17 cents per share sits at around the mid-point of valuation range.
You can download a copy of NDF Research's initiation report on SUDA by clicking here or visiting ndfresearch.com. We commend the report to you. Note - the usual disclaimers apply - click here.
Today we've published our initiation report on one such pioneer, a Melbourne-based regenerative medicine company called Cynata (ASX: CYP).
Regenerative medicine is the future – and will create some billion-dollar companies. Cynata is well placed for this race. Its Cymerus technology uniquely produces vast quantities of Mesenchymal Stem Cells (MSCs) from a single blood donation. This science, originated by Professor Igor Slukvin at the world-leading stem-cell labs of the University of Wisconsin-Madison, is exclusively licensed to Cynata. MSCs have wide application: heart repair, rebuilding bones and cartilage, reducing inflammation and much more. For example, in early 2017 (with backing from Britain’s NHS), Cynata initiated a UK-based Phase 1 trial in steroid-refractory acute Graft vs Host Disease (GvHD). Happily, international majors are noticing Cynata’s ground-breaking progress. In January of this year, Fujifilm (now a global leader in cellular medicine) initiated a strategic partnership with Cynata and optioned the GvHD indication in a deal with upfront, milestone and royalty payments. The company also made a $4m equity investment in Cynata. The future is on the way. Our target of $2.00 per share sits at around the mid-point of our probability-weighted valuation range of $1.03 per share base case and $2.77 per share optimistic case.
You can download a copy of NDF Research's initiation report on Cynata by clicking here or visiting ndfresearch.com. We commend the report to you. Note - the usual disclaimers apply - click here.
This note updates our 1 December 2016 note headlined ‘World-leading MRI diagnostic’. Resonance Health was originally built on FerriScan, an MRI-based test for iron overload disorders which gained FDA approval and CE Mark in 2005. FerriScan is widely regarded as the most accurate measure of Liver Iron Concentration in the world, being highly useful in managing a range of conditions from hemochromatosis to thalassemia to sickle cell disease. The diagnostic earns Resonance around A$2.0-2.5m in revenue a year. This could be higher we it not for the fact that at this stage FerriScan is not widely reimbursed. Resonance is gathering data on the utility of FerriScan and hopes to obtain further reimbursement in the future. In the meantime, it has developed a new technology based on machine learning (artificial intelligence) which it believes can markedly lower the cost of the FerriScan diagnostic. This new test can reasonably be expected to unlock new market opportunities, most notably in developing countries where there is a critical need for a robust diagnostic. We value Resonance at 7.6 cents per share base case and 14.5 cents per share optimistic case. Our target price of 11 cents per share sits at the midpoint of our DCF range.
Click here for our update report. For our initiation note from 1 December 2016 click here.
A new research note from NDF Research updates our 25 August 2016 note on Dimerix headlined ‘Hitting the GPCR spot’. Dimerix’s lead DMX-200 candidate, a combination of two existing drugs, irbesartan and propagermanium, has now completed its Phase 2a study in patients with proteinuria, which is symptomatic of a range of kidney problems. We consider the results of this study highly encouraging. Irbesartan is already used to treat kidney disease, and in Dimerix’s study 25% of patients showing a greater than 50% reduction in proteinuria beyond what was achieved with the highest dosage of standard of care therapy. The fact that 45% of the patients chose to continue with DMX-200 under a ‘Special Access Scheme’ arrangement after completion of their trial dosing suggests that the drug is working as expected. Dimerix will now prepare to initiate a Phase 2b towards the end of 2017, ahead of a potential Phase 3 in an Orphan kidney disease by 2019. Our 4-cent price target and Buy recommendation for Dimerix stays in place.
Click here for our update report. For our initiation note from 25 August 2016 click here.
Next week is an important milestone in my life. NDF Research (ndfresearch.com), which was founded on Friday 27 May 2016 to provide commissioned equity research focused on ASX-listed Life Science companies, will be a year old. Looking back over the last 12 months I have a lot to be thankful for, particularly the support and encouragement of great people I had yet to meet on that fateful day. Thank you to all of you who have contributed in some way to making it happen, or just passed on a kind word. Starting NDF Research was not something I did easily or lightly. The biotech and medical devices game may be a risky one, particularly in Australia and New Zealand, and requires a high risk appetite on the part of its participants, but I had never personally had the confidence to put out the shingle until last year, when I was past the age when I figured most entrepreneurs do their first start.
Partly what gave me the courage was the story of what I regard as the greatest startup in history, which took place in what is now the Startup Nation - the State of Israel - a long time ago. The startup I'm thinking of was, in effect, a spin out from the local building and fishing industry, and happened when a Great Man approached a couple of guys who had no experience in the field proposed for the new venture. The Great Man, aged about 30, said, simply, 'Follow Me'. That was a calling I have heeded myself, albeit imperfectly. We sometimes call the founder of the world's greatest startup the Great Physician, so I guess you could say His work was the forerunner of today's biotech and medical device industry.
Startups are perilous things. When the second-greatest startup in history was kicked off in Philadelphia in more recent years, the press release announcing it concluded with these these ominous words: 'We mutually pledge to each other our lives, our fortunes, and our sacred honour'. The 56 co-founders of that start - it attracted venture capital from 13 different jurisdictions, hence the high early headcount - knew that if they didn't get enough market share with their new venture it would not only fail but they would not be allowed to start another one. Their average age at the time was 44, which is comforting to this 46-year old entrepreneur. Thank heavens they succeeded.
Startups also tend to look a little messy at the beginning before they gain some traction. The third greatest startup in history was mostly staffed at the beginning by unskilled convicted criminals, many of whom had mental health issues and many of whom unfortunately died on the job. The venture had to rely almost exclusively on meagre government grants to survive. Indeed, it didn't take off until its main business changed from government services to agriculture a couple of decades after the start, but today people will move thousands and thousands of miles just to join this company. I was born into it. It's called Australia, and NDF Research, which I hope will go down in history as another great startup, is a recent spin-out company.
I will be in New Zealand all next week helping to build the Life Sciences sector of that great neighbour of Australia's. However the week after next, on around Monday 29 May, I intend to have a celebratory lunch for NDF's first birthday. If you'll be in downtown Sydney that day, just message me and I'll let you know the venue.
Founder and Senior Analyst,
Nisi Dominus Frustra.
Today we've published our evaluation report on Phylogica (ASX: PYC), a Perth-based biotechnology company focused on peptide drug development.
Peptides are potentially very valuable as the basis for future world-leading drugs, and Phylogica has a powerful discovery engine with its Phylomer platform. Most importantly, having discovered how peptide drugs can be delivered intra-cellularly, the company is able to address hitherto ‘undruggable’ targets. This should in turn open the way for a pipeline of potential blockbuster drugs. The company has already signed collaboration agreements with AstraZeneca, Roche, Pfizer and J&J. In due course, each of these can yield substantial milestone payments (one such already received). In addition to the outsourced projects, the company also has its own three, highly-prospective, in-house programmes focused on cancer targets. Our report has been commissioned by Phylogica to provide a third-party valuation of the company. We value Phylogica at 5.2 cents per share base case and 14.2 cents per share optimistic case. We regard 10 cents per share as a reasonable mid-range valuation for Phylogica.
You can download a copy of NDF Research's evaluation report in Phylogica by clicking here. I commend the report to you. Note - the usual disclaimers apply - click here.
Yesterday we initiated coverage on Optisan Imaging (ASX: OIL), a Melbourne-based company which has historically been an important player in the field of surgical microscopes and which is now being resurrected after around nine years in the wilderness. We think it is a phoenix rising from the ashes.
Optiscan is a Phase III company currently capitalised at only ~A$36m. Later this year Optiscan's partner, Carl Zeiss Meditec AG, the German manufacturer of optical systems, is expected to gain FDA approval for a new rigid endomicroscope that was developed by Optiscan and on which the two companies have been collaborating since around 2007. As we explain in our report, we believe the forthcoming Zeiss product has the potential to become a new gold standard for brain tumour surgery by making current practice obsolete. We suggest the market has yet to fully discover the late-stage nature of the Optiscan story.
Optiscan is a world-leader in the field of live micro-imaging, where powerful microscopes are used to image internal organs at the cellular level in real time for surgery and during diagnostic procedures such as endoscopy. In the 1990s the company introduced one of the first fibre optic confocal microscopy devices, while its Pentax ISC-1000, FDA approved in late 2004, was the world’s first flexible endomicroscope. The commercialisation of this landmark instrument stalled in 2007 and 2008 due to a combination of factors - Pentax was taken over by Hoya not long before the Global Financial Crisis, which led to cancellation of all Pentax-originated research and development, leading in turn to the discontinuation of the Pentax ISC-1000. A decade later, Optiscan finally appears to be recovering from the Pentax setback.
Last year a new leadership team took office at Optiscan, focused on gaining commercial outcomes from the historic A$100m that has been invested in the company since the 1990s. Their recovery plan has focused to date on helping Zeiss deliver the new endomicroscope product. We see that product as well as the new Optiscan pipeline helping to re-rate Optiscan stock. We value Optiscan at 11 cents per share base case and 25 cents per share optimistic case. Our 17-cent target price sits at around the midpoint of our valuation range.
You can download a copy of NDF Research's first report on Optiscan by clicking here. I commend the report to you. Note - the usual disclaimers apply - click here.
Today we're initiating coverage on Anatara Lifesciences (ASX: ANR), a Brisbane-based company whose lead product, called Detach, may be able to strike a blow against the scourge of antimicrobial resistance.
Have you noticed lately how worried people are getting about antimicrobials not working? And no wonder. In the US greater than 20,000 people die every year because of infections that antimicrobials can't deal with, thanks to previous overuse of what were once good drugs. That's one reason why major QSR operators like McDonalds and Taco Bell are now scrambling to remove antibiotics from their supply networks, and why the US Congress passed the GAIN Act in 2012 to provide incentives for developers of next-generation antimicrobials. We see Anatara Lifesciences as benefiting from the trend towards significantly less antibiotic use in the clinic and the food chain.
Anatara Lifesciences is getting ready to launch its first product this year. Detach is a non-antibiotic treatment for production animals such as cattle and pigs designed to reduce gastrointestinal disorders in these animals, thereby increasing meat yield. Anatara filed for Australian approval of Detach in October 2016 and expects to be selling the product commercially to pig farmers in 2017. We see significant upside for Anatara from an option granted last year to the animal health major Zoetis over a worldwide license for Detach’s use in production animals. Anatara has argued that Detach’s mechanism of action, which doesn’t involve killing pathogens directly, makes the product one potential solution to the antibiotic resistance problem. Anatara is currently looking at human applications for Detach, where the market opportunity in Inflammatory Bowel Disease and other gastrointestinal diseases in need of new anti-inflammatory approaches is significant. We value Anatara at $2.22 base case and $5.94 optimistic case using a DCF approach. Our target price of $4.00 sits at around the midpoint of our valuation range.
Click here to check out the research. Note - the usual disclaimers apply - click here.
Here's this afternoon's Livewire Markets posting - visit www.livewiremarkets.com. Livewire is Australia’s source of financial intelligence.
Days like today make me wish I was back in stockbroking because Sirtex's 'Trading Update' has created the kind of contrarian play I love. Thanks to slower SIR-Spheres sales, Sirtex's constant currency EBITDA in 1H17 will fall 9-16%. As I write Sirtex stock is down 41%, making people think the world's just ended for this company. I argue, by contrast, that nothing serious has gone wrong. Yes, you heard me right. Sirtex has cited increased competition for patients, a new drug approval for salvage metastatic colorectal cancer, and tighter reimbursement. None of these should really worry Sirtex management because once SIR-Spheres are used for more than salvage therapy, Sirtex's growth profile will be assured. We know from numerous small studies that the product works in liver cancer. That's started to be borne out in the larger studies Sirtex has designed to move SIR-Spheres from 'last line' to first line', which is where the big money is. We at NDF Research don't cover Sirtex (yet), but I suggest investors taking a medium-term view may find a lot to be encouraged about.
Note - the usual disclaimers apply - click here.
Last week NDF Research initiated coverage on Resonance Health, a Perth-based company which over a decade ago developed the world’s first non-invasive diagnostic for iron overload, an MRI-based test called FerriScan. This test, approved in the US and Europe since 2005, has been the basis of a small but growing business for Resonance currently worth A$2.0-2.5m p.a. in revenue. A subsequent MRI-based product, called HepaFat-Scan, for the measurement of the liver fat fraction, gained FDA approval in December 2013 and CE Mark in July 2014 and Resonance continues to work on groundbreaking new MRI-based diagnostics. Resonance currently has a market capitalisation of only ~A$10m. We believe this is because the full potential of FerriScan has yet to be realised as a result of reimbursement challenges. That said, we also believe that Resonance is currently undervalued and that with increased usage and potential reimbursement wins for FerriScan, increased awareness and uptake of HepaFat-Scan, and the introduction of new products, there is potential for the market to re-rate the company over time. To read our initiation report on Resonance Health click here.
Here's this morning's Livewire Markets posting - visit www.livewiremarkets.com. Livewire is Australia’s source of financial intelligence.
Ian Frazer, of the University of Queensland, was Australian of the Year in 2006 because his research created Gardasil, the cervical cancer vaccine. Like all good Professors, Frazer hasn't stopped generating Next Big Thing ideas, and one of them is DNA vaccines to prompt a patient's own immune system to fight disease. I've argued for a while now that the first approved DNA vaccine is coming soon, and Frazer's approach, being developed by Admedus, may be a contender. Admedus's first vaccine candidate works against HSV-2, the virus that causes genital herpes, which is a billion dollar opportunity. Yesterday Admedus announced an interim analysis from 20 patients in a Phase IIa of the HSV-2 vaccine - it cut the viral shedding rate in the treated patients by 58%. Early days, but very encouraging. Meantime Admedus is steadily growing sales of an approved cardiovascular tissue patch called CardioCel, created using the company’s ADAPT technology, which allows animal tissue to be prepared for use in humans without the usual calcification issues. So there's a real business in Admedus, and some exciting Blue Sky.
Note - the usual disclaimers apply - click here.
Here's yesterday's Livewire Markets posting - visit www.livewiremarkets.com. Livewire is Australia’s source of financial intelligence.
It was the kind of response ASX-listed Life Sciences companies wish they could have more often. The Adelaide-based LBT Innovations announced on Monday 10 October that it had gained FDA approval for APAS, short for 'Automated Plate Assessment System'. When the market heard the news it bid the stock up from 19 cents the previous Friday to a closing high of 87 cents a week later. There's a lot to be excited about. APAS is a genuine breakthrough for pathology laboratories everywhere because up until now reporting of cultures from agar plates, in order to see what pathogen is in the sample being cultured, has been a labour-intensive exercise. APAS, an artificial intelligence technology, automates the imaging and interpretation of the plates. It's a productivity tool that around 27,000 labs around the world have long been crying out for, and LBT and its partner, the Swiss company Hettich AG, will be marketing it from next year. There's more where APAS came from - LBT is now working on Woundvue, a handheld device to assess chronic wounds to facilitate better treatment.
Note - the usual disclaimers apply - click here.
Back in late August we initiated on Dimerix (ASX: DXB), a Melbourne and Perth-based drug discovery company being built around new ways to identify G Protein-Coupled Receptors. Today we're updating our coverage of Dimerix with a research note on some recent data, which we think are very encouraging, from the company's first clinical study of DMX-200, its lead candidate.
DMX-200 is a combination of two existing drugs, irbesartan and propagermanium. The product is now in a Phase II study in patients with proteinuria, which is symptomatic of a range of kidney problems. Following recent guidance for the FDA, Dimerix is now making plans to take DMX-200 into a pivotal study in Focal Segmental Glomerulosclerosis, an Orphan kidney disease. Dimerix reported on 4 October that 21 out of 30 patients have now been dosed in this study. Of 11 patients who have reached or passed the mid-point of the study, three have shown a ~ 50% reduction or greater in proteinuria over and above standard of care, which is very encouraging. Final data from Part A of the Phase 2 study is expected in the second half of next year. We value Dimerix at 2.4 cents per share base case and 5.8 cents per share optimistic case. Our target price of 4.0 cents per share sits at the midpoint of our DCF range.
You can download a copy of NDF Research's first report on Dimerix by clicking here or visiting ndfresearch.com
176 Life Science patents (classification A61K) were issued by the US Patent and Trademark Office on Tuesday 18 October 2016 (click here). None went to Australian but one was granted to a New Zealand assignee.
ManukaMed, a company based at Masterton in the Wellington region, has been granted US Patent 9,469,675 for Anti-inflammatory proteins and methods of preparation and use thereof, which covers a modified version of the honey glycoprotein apalbumin with greater anti-inflammatory properties than an unmodified apalbumin. The protein comes from Manuka honey, that is, honey from the Manuka tree (Leptospermum scoparium) native to New Zealand.
Manuka honey is one of the reasons that we argue New Zealand is on the cusp of a biotech and medical devices boom. To undestand what we mean check out out recent article headlined '100% Bullish on the New Zealand Life Science sector'.
Over the last twelve months the Australian Life Science sector has been granted 114 US patents, versus 134 in the previous corresponding period. In New Zealand over the last twelve months the Life Science sector has been granted 16 US patents, versus 12 in the previous corresponding period.
To look at US Life Science patent issuance since the beginning of 2014 to Australian assignees, click here. For US Life Science patent issuance to New Zealand assignees click here.
Here's today's Livewire Markets posting - visit www.livewiremarkets.com. Livewire is Australia’s source of financial intelligence.
A year ago it looked like disaster had struck Osprey Medical (ASX: OSP). In June 2014 the company had gained FDA approval for AVERT, a system that reduces the amount of contrast dye interventional cardiologists use during heart procedures. Contrast dye lets cardiologists see what's going on under X-Ray, but can be nephrotoxic (ie damaging to the patient's kidneys) so any system that reduces its use is valuable. Post FDA approval, Osprey ran a randomized, controlled study of AVERT to strengthening its marketing claims. When the data came in, in October 2015, it showed that AVERT had reduced the average amount of dye used, but hadn't generated a statistically significant difference in Contrast-Induced Nephropathy. Osprey stock crashed. However a 'post-hoc' analysis of the data showed that the reduction in kidney injury was real for patients with pre-existing stage 3 kidney disease, where 'standard criteria' was used to measure the reduction. Meantime Osprey had gained FDA approval for a more automated version of AVERT called Dyevert. That product is now selling well. Disaster effectively avoided, although Osprey Medical stock has yet to recover.
Note - the usual disclaimers apply - click here.
Two new PCT patent applications relevant to the Australian and New Zealand Life Sciences sector published this week: