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Healthcare - Medical - Devices - NASDAQ - US
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EARNINGS CALL TRANSCRIPT
EARNINGS CALL TRANSCRIPT 2015 - Q3
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Executives

Mike Houston - Vice President of Commercialization and Communications Sonny Bal - Chairman and Chief Executive Officer Ty Lombardi - Principal Accounting Officer and Vice President, Finance.

Analysts

Mike Matson - Needham & Company Jeffrey Cohen - Ladenburg Thalmann.

Operator

Good day, ladies and gentlemen, and welcome to the Third Quarter 2015 Amedica Corporation Financial Results Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions] As a reminder, this conference is being recorded.

I would like to introduce your host for today’s conference, Mr. Mike Houston, VP of Commercialization. Mike you may begin..

Mike Houston

Thank you, Krystal. Good afternoon, and welcome to Amedica Corporation’s third quarter 2015 earnings conference call. On the call with me today are Dr. Sonny Bal, Chairman and Chief Executive Officer; and Ty Lombardi, Principal Accounting Officer.

By now, everyone should have access to the earnings release for the period ended September 30, 2015 that went out this afternoon at approximately 4:00 p.m. Eastern Time. If you have not received the release, it’s available on the Amedica’s website at www.amedica.com. This call is being webcast, and a replay will be available on the Company’s website.

I’d like to remind you that certain items that may be discussed in today’s call are not based entirely on historical facts. These items should be considered forward-looking statements, and are subject to many risks, uncertainties and other factors that are difficult to predict and may affect our businesses and operations.

As a result, our actual results may differ materially and adversely from those expressed or implied by our forward-looking statements. Some of these risks, uncertainties and other factors are set forth in our SEC filings.

We undertake no obligation and do not intend to update any forward-looking statements, as a result of new information or future events or circumstances, arising after the date on which it was made. With that, I would now like to turn the call over to Dr. Sonny Bal. Dr.

Bal?.

Sonny Bal

Thanks, Mike, and good afternoon everyone. Welcome to our third quarter 2015 earnings results conference call. I will begin by giving an update of Amedica’s recent operational highlights and afterwards, Ty Lombardi will provide us details on the financial results for the quarter and then we’ll open up for questions.

I’d like to begin today’s call by sharing how pleased I am with the progress we’ve made throughout the company from our financial and operational standpoint. Despite, what we’ve experienced in the market in the last two trading days, I was assure our listeners that there is nothing wrong with the company.

We are in a strong financial position, we are compliant with all debt covenants and we’ve made substantial progress in our goals and we’re executing on our vision all of which Ty Lombardi and I will outline later on in this call as Ty will outline also.

We’re able to reduce year-to-date operational cash burn levels by 38% from last year, while also reducing our debt principal balance. This is a significant positive impact from the restructuring we completed at the beginning of this year. Result for these actions are beginning to show and these vital to our continued success going forward.

I strongly believe that we have turned the corner as a company as we continued toward an increasingly positive trajectory.

I am very optimistic in our ability to increase market share for silicon nitride materials, launch new and exciting products, engage more surgeons and expand our research and development, while increasing value for our shareholders.

We have made excellent progress in all levels of our business this past quarter with the release of new products and expansion into new geographic market, much of which I’ll touch on later.

We recently finalized definitive agreements to raise up to $15 million, which will be used to strengthen our balance sheet and help to get us out of some toxic previous debt and will provide stability to our balance sheet and cap table.

With this table and improved balance sheet, we are better positioned to develop innovative products and renderings and compositions of our materials and ongoing effort. Amedica has a strong infrastructure in place with top level manufacturing, good management, business development and research and development teams.

Our silicon nitrate materials are truly unique and differentiated and we believe they are better than anything on the market. As my team and I are out in the field on a regular basis, it’s very good to see a renewed excitement about Amedica and silicon nitrate biomaterial again.

I’ve talked to many surgeons, doctors, investors, distributors, potential primate label and OEM partners all across the world and they are excited by the quality and potential of our ceramics. Another big move we undertook during the quarter was to appoint Dr. Giuseppe Pezzotti to our Scientific Advisory Board.

Professor Pezzotti is a world-renowned materials scientist that will help us further develop our silicon nitrate technology platform, it feel that is very close to him. Dr. Pezzotti holds three doctoral degrees in material science engineering, solid state physics and medical sciences.

With that excellent background, he will be pivotal to provide further validation of the uniqueness of our proprietary silicon nitrate composition and advance the science even more.

Since joining us this quarter, Professor Pezzotti has provided a webcast on the physics, chemistry and mechanical behavior silicon nitrate and how it compares to biomaterials.

He will be a part of future webcast in the coming months regarding the team’s research findings which have the potential to yet further improve clinical outcomes of our proprietary biomaterial.

In regards to products, we announced the addition of our articulating inserter for minimally invasive Transforaminal Lumbar Interbody Fusion or TLIF procedures and the relive of a silicon nitrate Lateral Lumbar Interbody Fusion Device.

Starting with the articulating inserter, we are getting very positive feedback that this minimally invasive and surgery approves visibility and provides another access option for surgeons. And we are already beginning to see a positive impact on the business during this beta testing.

The scorpion articulating inserter will be made available to a field of surgeons and distributors as early as next week.

Moving on now to Valeo II Lateral Lumbar Interbody Fusion Device; we underwent an initial launch in September to make the device commercial available, which includes a second generation instrumentation to improve patient safety and surgeon ease of use.

With the first phase of the Lateral Lumbar System complete, our product development team is now undertaking the task of creating additional sizes and footprints of the Interbody device to make the system more widely available for a myriad of procedure and patient anatomy types.

In addition to these two products, our product development team is also deepened the process of updating a Preference 2 Metals System. I am proud to announce that the first phase of this project was completed during the quarter, which has greatly improved an update of the instrumentation within the system.

And again, we’re seeing some early positive impact on our financial results as more systems will be coming online during Q4 and into Q1 next year. These actions which are critical to offset recent declines in our metals revenue are also paramount where our ability to fully update our Preference Metal Systems.

Speaking of which a Preference Elite System, the new and much improved metal system remains on track to be launched into the field during the second half of next year.

This is very significant for us because this new metal system will not only have a pull through effect on a silicon nitrate sales which we’re already seeing with recent instrument updates but this system will also arrival much of what’s out there in terms of state-of-the-art products in the market today, allowing surgeons to have just one rep in the operation room during the procedure.

In addition to a further updated instrumented system, Preference Elite will also future a cannulated screw and design amenable to minimally invasive procedures.

Looking forward to 2016, we’ll continue to keep our product development teams busy because we’re considering several new projects such as a standalone fusion device, additional versions of our Composite Interbody Fusion Device and also a second generation formulation of our core silicon nitrate technology platform.

All of which we can details at future date. These are very exciting times that Amedica all made possible by improved financial and cash position. Continuing with similar success we’ve experienced in the product development side, discussions with both private label and OEM partners continue to be strengthened throughout the year and quarter.

We continue to draw interest and navigate opportunities that present the best option for our company. We have been working diligently to secure and finalize agreements on that front. Some agreements take longer than other to finalize but I remain confident and optimistic for the future of a hybrid OEM and private label strategy.

Our business development strategy also remains very strong as we educate, share and present data to our peers about the benefits of silicon nitrate and why it’s the perfect biomaterial. We strongly feel the strategy is that an infection point and this was obvious during the recent North America Spine Society Conference in Chicago last month.

There were several discussions and presentations during the week, not by us, by others, which furthered our claim that silicon nitrate is the ideal biomaterial. These presentations and discussions range from explaining why PEEK or plastic cannot fuse its own to how ceramics just as silicon nitrate play a critical role in the spinal fusion process.

As several surgeons, manufacturers and others from the industry came to our booth. The overwhelming conversational theme was which biomaterial they should more to or away from PEEK. Needless to say we had a busy time at NAS this year meeting with influential context about the retail and OEM private label side of the strategy.

Those conversations were both educational and encouraging and they are continuing. While there are other materials in the market today which provide increase surface topography to stimulate bone in growth, keep in mind silicon nitrate is the only material in the world that offers the world first natural nano-surface biotechnology.

This natural technology includes increased surface area for osteoblasts and proteins, but also contains a unique surface chemistry which lends to the materials anti-infective and osteopromotive properties claims that no other material out there today can make. And might I add, we can engineer that surface topography to suite particular needs.

Our business development team has been very active and getting in front of the influences and building interest. These discussions have been limited to spine for a larger spectrum of the potential medial applications, the silicon nitrate will be ideal for.

The science behind our material is concrete and strong and getting the word out of conferences NAS is paramount. We are actively accessing these partnerships here domestically as well as in Europe, Latin America and Asia, the medical application that includes spine, hip, knee, dental and others.

As you may have noticed recently, we secured our first joint development agreement for dental application this quarter and we’re moving closer to hip and knee, which we will touch on later. Our increased efforts to expand the use of silicon nitrate through our existing sales and distribution channels are paying off.

Our improved financial situation is exciting and offers the Amedica grade upside potential moving forward. I am convinced that there are many opportunities to help strengthen the existing distributor of surgeon base and build future on it. Progress with peer reviewed publication is also going very well and we are ahead of schedule on that font.

We plan to announce two more accepted publications later this month, one of which includes a future publication in The Journal of the European Ceramics Society. It is a solid body of work with over 600 references that outlines a key role ceramics namely silicon nitrate play an orthopedic applications.

We are very proud of this key publication and it has already turned more than a few heads in the orthopedics and ceramics research communities and gotten us invitations to conferences.

I am also proud to note that our presents and discussions at this year’s International Society of Technology in Arthroplasty or ISTA abbreviated was a success, our presentations all of which were accepted at the conference.

We’re well received and one of our submitted abstracts regarding surface modulation of silicon nitrate ceramic secured the Transatlantic Orthopaedic Congress Abstract Award. Our R&D team continues to validate our unique material claims through in Vivo and in Vitro studies which have yielded several whitepapers and peer viewed publication this year.

This approach has provided additional fire power for our sales and business development teams to make new contacts and solidify new deals. Each new peer reviewed article makes it easier to show the medical community and potential OEM and private label partners, the validity of our unique silicon nitrate clinically benefits.

This strategy has been very effective and our conversation with other in the field have become more responsive allowing for a large market penetration which increasing potential sales. Feedback we continue to receive as that silicon nitrate is a super material that offers excellent results and unique benefits.

Please stand behind our evidenced based outcomes and we will continue to bring these findings to the public. We are committed to our data expansion efforts and we will continue to push those.

There is much to do on this front and our scientific team continues to build on the portfolio of peer reviewed publications related to the basic material properties of silicon nitrate throughout the year.

We are the leaders in nano-technology surfaces for medical applications and these scientific papers will continue to provide the knowledge base to further improve up on an innovative technology platforms.

Moving on to recent international endeavors, we noted in our previous call that we had clearance for our first generation silicon nitrate into body fusion devices and instrument sets in Brazil.

I am pleased to announce that our first shipment of product has cleared customs and we anticipate further developments and announcements from the region in the coming months. And Brazil is a sizable market with a population of more than 200 million people and we look forward to experiencing incremental growth as that region comes fully online.

Our business development efforts both internationally and domestically have been vital for finding us key new markets and opening additional sale channels. We look forward to further cultivating this opportunity in Brazil and other markets while accelerating the adoption of silicon nitrate for use in biomedical applications.

Now clinical outcomes and peer reviewed scientific data are vital to our success going forward in the unique biomaterial. It’s a data drive world out there. our customer need data to add scientific credibility and to validate the use of silicon nitrate over other materials that have been used in medical applications.

Together, our studies will continue to provide us with a solid clinical foundation that our sales and marketing team can build on and there are surgeon and hospital customers that our OEM and private label partners need in order to adopt our technology more widely.

In regards to regulatory efforts, FDA has request for 24 month clinical performance data was fulfilled early this week. The FDA is now able to consider further clearance of our Cervical Composite Silicon Nitrate Interbody Device, that’s already been used in Europe. This submission is important to us.

We spend the necessary time during the data gathering and analysis process to ensure that we had everything right before submitting it to the FDA for further review. And we feel confident in our submission as we’re able to work with the FDA and other key partners as efficiently as possible.

And we look forward to a favorable outcome, the anticipated timeline being first quarter of 2016. With the FDA decision on the horizon, we continue to be diligent in discovery of additional innovative solutions.

Our Femoral Head Testing has progress nicely and we received very constructive feedback on our proposed where a testing protocol from the FDA. We now have a clear understanding of the pathway to market for our silicon nitrate Femoral Head in the United States.

These FDA comments will ensure that the testing of our material has compared with the ceramic predicate devices on the market will meet or exceed every existing testing standard.

We anticipate being able to provide additional details on this testing soon and look forward to the results of a direct comparison with all other Femoral Head materials out there. Interest in our silicon nitrate continues to grow and we recently announced a joint development agreement for dental applications.

This agreement marks a first step into a market outside of spine. But this is only the beginning. Worthington is our first dental OEM customer and we will work closely with them to develop prototype and manufacture. They have patterned it in very creative dental implant system.

This new alliance into a new market allows for further acceptance of silicon nitrate for medical applications and validates the advantages of our proprietary biomaterial and as compared to anything else out there.

From a manufacturing standpoint, our team continued to exceed expectations this quarter as production yields increased beyond 97%, which is a sizable increase from the same period last year and a strong continuation from the previous quarter.

This high yields speaks to the tight control process that in place despite the many complicated steps is takes to manufacturer our silicon nitrate devices. Additional opportunities, we increased yield and reduced production throughout. Throughput time this year have been identified and will be implemented throughout the year.

And before I turn the call over to Ty Lombardi to review the financials, I like to remind our listeners why we’re so thrilled about Amedica’s bright future. We are truly a unique highly differentiated company one of its kind in the world.

We’re the only company that develops and commercializes silicon nitrate ceramic as a biomaterial platform for use in spine and potentially many, many other medical applications. We have the only FDA and CE cleared silicon nitrate manufacturing facility anywhere in the world.

We are unique for four reasons; one, we sell branded products directly to hospitals through a sales force and distribution structure. Two, we can private label these innovative silicon nitrate products to other companies, looking to broaden their product portfolio.

Three, we’re able to develop OEM partnership where we take a company’s existing design or devise made out a legacy inferior material like plastic or metal and we can ceramasize it so to speak into silicon nitrate very effectively thereby increasing a strength biocompatibility, making it anti-infective and we can customize it.

And four, potential, we already make Superior Interbody Spinal Devices that are sold in the U.S., Europe and South America and look to add other medical applications.

There are numerous peer reviewed publications that speak to the many benefits of silicon nitrate in healthcare and we’re just beginning to scratch the surface of what this fantastic biomaterial can do in the current healthcare market.

This multi-pronged strategy will allow us to capture additional market share, while achieving profitability on accelerated timeline as compared to our peers given the superior benefits of our biomaterial technology platform. The restructuring changes we made at the beginning of this year have truly positioned Amedica for success over long haul.

We are now on pace to reduce manufacturing cost 20% year-over-year through a combination of lean and continuous improvement initiatives. Driving down manufacturing cost has been a priority for us and we continue to execute one cost per piece or our cost per piece is very competitive with other materials that are now commercially available.

We are continuing to growth our existing private label in OEM business within upcoming metals launch system in 2016, some metal updates in fourth quarter. We are in great shape going forward. This unique hybrid sales strategy is made possible by the hard work and dedication of our finance team.

The recent equity financing and strong improvements we made to operational expenses now given us the necessary runway to fully execute on the strategy. With that I’ll now turn the call over to Ty Lombardi, who will discuss our financial results.

Ty?.

Ty Lombardi

Thank you, Dr. Bal. I am pleased to discuss the financial results of the company during the third quarter 2015. Our total revenue for the quarter was 4.8 million, down 19% from the prior year period and was primarily driven by lower metal business.

As to our product mix, our silicon nitrate products were responsible for 52% of our overall product revenue during the quarter compared to 47% of our overall product revenue in Q3 of 2014. Silicon nitrate sales decreased by 300,000 or 10% as compared to the same period in 2014.

This decline is primarily attributable to the loss of the few surgeons during 2015 and consequences from our restructuring. This is partially offset by the addition of new surgeons as well as international and private label sales. Our non-silicon nitrate sales during the quarter declined by 27% year-over-year.

This decline was due to a lack of sufficient diversity and in our customer base and is the level of activity declined among a few key surgeons greatly impacted our top line results for the quarter. Furthermore given the important role, our metals products are pulling additional silicon nitrate sales.

We are working to diversify our metal user base as Dr. Bal mentioned. We’re also investing our metals portfolio in order to improve surging ease of use and bring it with other products used in the market today. Third quarter 2015 gross margins ended at 66% of total sales as compared to 68% during the prior year period.

Although we have reduced our product cost, production efficiencies and lower overhead cost, the decline in gross margins relative to private label and international sales during the third quarter of 2015, which have lower gross margins due to lower selling price but higher operating contribution margins and sale commissions are paid and there are less operating expense required to support those sales.

Our manufacturing team continues to drive efficiencies and cost savings on our cost of goods sold by keeping labor cost well and improving our quality in tooling system. Research and development expenses for the quarter decreased by 300,000 or 15% to 1.7 million when compared to the prior year period.

This decrease was primarily due to 500,000 decrease in stock based compensation and 700,000 decrease in personnel-related other development cost which are partially offset by fewer expenses being allocated to inventory and more to research and development activities due to lower production.

Clinical studies and research expense as well as the development of an upgraded metal system to support the utility of our silicon nitrate products will continue to play a role in any year-over-year offsetting decreases in R&D spend.

General and administrative expense decreased 1.5 million or 51% to 1.4 million in the third quarter compared to 2.9 million last year. This decline in expenses primarily due to 700,000 decrease in stock based compensation and 800,000 decrease in personnel-related cost resulting from the restructure in the first quarter of 2015.

We expect general and administrative expenses levels to decline moderately through 2015 as cost saving measures have been implemented to improve financial performance, increased operational efficiencies and strengthen the company’s value proposition.

Sales and marketing expenses totaled 2.9 million in the quarter compared to 4.8 million in the prior year period, a decrease of 40% or 1.9 million.

This decrease was primarily due to 500,000 decrease in stock based compensation, 600,000 decrease in commission due to oversell and 800,000 decrease in personnel-related cost, consulting and other operating expenses as we have reduced operating cost on 2015.

We expect sales and marketing cost in 2015 to decrease as compared to 2014, due to the implemented cost saving measures. Operating expense for the third quarter of 2015 declined by 38% or 3.7 million from the prior year period to 6 million.

This year-over-year decline in operating expenses is primarily due to the actions taken by the company to simplify the organization and align financial objectives earlier in year as well as lower commission cost and 1.7 million reduction in stock based compensation expense during the third quarter of 2015.

Our GAAP net loss for the quarter was 10.1 million compared to a net loss of 4.9 million in the prior year period. This increase in net loss was primarily the result of an 8 million increase in the fair value derivative liability. This was partially offset by reduced operating expenses a 2.7 million for the period.

By December 31st, 2015, we anticipate the majority of our derivative liabilities will be extinguish as a result of the completion of the most equity financing.

Turing to adjusted EBITDA, which we defined as earnings before deduction for interest, taxes, depreciation, amortization, stock based compensation, changing fair value derivative liabilities, offer cost, gain or loss on extinguishment of debt and gain or loss on extinguishment on derivative liabilities was a loss of 2.1 million for the third quarter of 2015 compared to a loss of 2.3 million for the prior year period.

As of September 30th, 2015, our cash balance was approximately 11.3 million. Our total debt principal obligations were approximately 20.1 million. I would also like to point out that although total sales were down 19% for the quarter, our operating cash burn has decreased and we remain on track with projected cash balance forecast.

We anticipate receiving an additional 10 million from the recent equity financing which we believe will allow us to remain in compliance with all debt covenants to quarter three of 2016. As Dr. Bal mentioned earlier in the call, our year-to-date operational cash burn decreased by 38% of $4.4 million.

The decline in total cash burn year-over-year was driven by 32% decrease and operational cash burn of 1.3 million in the third quarter of 2015 as compared to the prior year period. This speaks to the wonderful job our teams have done in reducing operating expenses and properly managing cash levels.

We remain on the proper trajectory to reduce total cash burn and we’re making continued progress on this front with each passing months and quarter. Additionally, I’d like to provide an update on the 2015 guidance we shared earlier this year.

We’re revising our previously stated estimate of total annual revenue to the range of 19 million 19.5 million, which implies a flat to modest decline in 2015 silicon nitrate annual sales as compared to the prior year period.

We also expect the impacts on previously announced financial and operation alignment actions to deliver 5 million to 6 million of annualized operating benefit. These changes are anticipated to continue to reduce total cash burn, increase financial sustainability and strengthen the balance sheep.

Positioning Amedica to maintain compliance about debt covenants into the third quarter of 2016 and achieving operating cash flow breakeven during the fourth quarter 2016. We also anticipate our debt principal balance to total approximately 17.5 million by the end of 2015, a decrease in total debt by approximately 28% from the prior year period.

We maintained previously stated guidance on operating quarterly cash burn rates between 2 million and 2.5 million in 2015 on an annualized basis.

Additionally, we are maintaining our previously stated guidance of four total OEM and private label partners to be announced during the balance of 2015 leaving us with one remaining partner to announce this year.

We’ve remained committed to improving the focus and profitability of Amedica, these strategic measures will allow us to execute on the development of our core silicon nitrate technology and aligning sales, marketing, and product and business development teams to drive broad product portfolio growth and adoption of silicon nitrate. Back to you Dr.

Bal..

Sonny Bal

Thanks Ty. Operator will you now please instruct the callers on how to join the queue for questions..

Operator

Thank you. Our first question comes from Mike Matson from Needham & Company. Your line is open..

Mike Matson

Hi, thanks for taking my questions. I guess I just wanted to know first of all what the balance sheet is going to end up looking like after the financing in completed.

I guess just for timing on that, I mean is it done or is it still happening?.

Ty Lombardi

It is still occurring. The financing will come in two additional tranches, one which we expect here soon and then another one before the end of the year.

At that point as like we indicated, we would expect our debt, principal balances to be approximately 17.5 million thereby reducing our debt significantly and our derivative liabilities to be - the majority of them to be gone by the end of the year..

Mike Matson

And your share could, would you expect that to look alike?.

Ty Lombardi

It’s a little unclear right now. Currently we have approximately 79 million, we had on fully diluted at September 30th, we have approximately 45 million with warrants and that will depend on the price and the timing of that. But we’ll definitely increase in addition to the 79 million it’s currently outstanding right now..

Mike Matson

Okay. Thanks. And then question for Dr. Bal.

I was wondering, how does the tier date from CASCADE look, I mean - do the efficacy continue?.

Sonny Bal

Yeah, I mean no surprises there as you can imagine bone that healed at 12 months, say it healed at 24 months and beyond, so the FDA wanted 24 month data. And when we shared our 12 months data, the poor silicon nitrate not surprising heal as well as the patient’s own bone. This device is already in use in Europe, so none of this is too surprising.

But the short answer to your question is, yeah the data looks about the same as the 12 month data..

Mike Matson

Okay.

And then just as far as the timing, I mean the press release said FDA says 90 days to your back to you, so I mean I would put a count like first quarter when you expect some sort of response, correct?.

Sonny Bal

Correct, that’s about right, that’s maybe sooner but that’s about when we expect the response. And we’ve taken the time to put in a strong application answering the all the questions they asked the first time around. So hopefully it’s just 90 days..

Mike Matson

Okay. Alright, that’s all I have. Thank you..

Sonny Bal

Thank you, Mike..

Ty Lombardi

Thank you..

Operator

Thank you. Our next question comes from Jeffrey Cohen from Ladenburg Thalmann. Your line is open..

Jeffrey Cohen

Hi gentlemen, how are you?.

Ty Lombardi

Good, how are you..

Jeffrey Cohen

Just fine.

So just a few questions around, if you could review with me the three partners thus far, one was Worthington in the dental indication, and could you just review with maybe other two?.

Sonny Bal

The other two, we signed a letter of intent in the summer, earlier we have not named that partner and we are working diligently with them to ensure that they have a clear regulatory pathway for silicon nitrate and the products that they will wish to do in OEM, have us manufacture their product in silicon nitrate.

So we are hopeful, things are encouraging, we’ve had good news along that font over the last two months and we’re tending to work with them and hope to continue to move that forward to a definitive agreement here over the next period of time. And then we signed another private label partner that we announced last week.

At this time, we haven’t named them as they from a competitive reasons decided not to be named at this point. So those are the ones that we have signed this year and we are looking to sign at least one more by the end of this year..

Jeffrey Cohen

Okay and could you indicate or confirm the last two, are they specific to spine?.

Sonny Bal

Yeah, they are specific to spin..

Jeffrey Cohen

Okay.

Have you any feedbacks from here, any commentary that you could provide as far as the core silicon nitrate product that’s been launched in Europe as far as some of the feedback from physicians or feedback from images that have been taken?.

Sonny Bal

I mean the feedback we’re getting is in line with what I wouldn’t anticipate as a ceramic scientist and as a physician. Of course materials in general are osteo-conductive meaning the movement grows into them, so that’s not a surprise. This material has additional properties that particularly attract osteocytes or osteoblasts more informing cells.

There is no negative news. There is no adverse reaction to it. It’s worked very well in Europe. The American FDA requires more and that’s why we have to submit the application here. But the reason this is particularly exciting is given the surface nano-chemistry of the material and its bioactivity.

First, the mirror creation of a poor substrate like that is remarkable. No other ceramic can do it. Two, it goes beyond being osteo-conductive, representing a much larger surface area that’s bioactive to bone, to stem cells, to soft tissues, to the biological environment we put in.

So I am very excited that this material will go well beyond its current application and the composite fusion device..

Jeffrey Cohen

Okay, perfect, thank you. That’s it from me..

Sonny Bal

Thanks, Jeff..

Operator

Thank you. And this concludes our question-and-answer session for today’s conference. I would now like to turn the conference back over to Sonny Bal for any closing remark..

Sonny Bal

Thank you. And thanks to everyone who participated on the call. I would like to reiterate my excitement for this year and next and beyond.

We truly believe the orthopedic market is that an inflection point given a 30 or 40 year history of biomaterials without much innovation at all and naturally it’s looking for innovation, which has been evidenced in our recent discussions with OEM partners, private label partners, distributors and every conference we’ve been to.

This is an incredible opportunity for our company to prove the benefits of silicon nitrate which almost prove themselves and get wider adoption of the material. I am very optimistic and proud that our team can take advantage of this opportunity with our recently improved financial position. And I look forward to providing another update in the future.

Thank you..

Operator

Ladies and gentlemen, thank you for participating in today’s conference. This does conclude the program and you may all disconnect. Everyone have a wonderful day..

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