Q1 2024 Avinger Inc Earnings Call
Operator: Greetings and welcome to the Avinger first quarter 2024 results call. At this time, all participants are in a listen-only mode, and a question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note, this call is being recorded. I will now turn the conference over to your host, Mr. Matt Kreps. Mr. Kreps, you may begin
Greetings and welcome to the Harbinger first quarter 2024 results call.
At this time all participants are in a listen only mode.
Speaker Change: A question and answer session will follow the formal presentation.
Speaker Change: If anyone should require operator assistance joined the conference. Please press star zero on your telephone keypad.
Speaker Change: Please note this call is being recorded.
Speaker Change: I'll now turn the conference over to your host Mr. Mark Kratz, Sir you may begin.
Speaker Change: Thank you and thank you also participate in todays call.
Matthew Kreps: Thank you, and thank you all for participating in today's call. I'd like to welcome you to Avinger's first quarter 2024 conference call. Joining us today are Avinger's CEO, Jeff Soinski, and principal financial officer, Nabeel Subainati.
Speaker Change: I'd like to welcome you to.
Speaker Change: You haven't just first quarter 2024 conference call.
Speaker Change: Joining us today, our average or a CEO, just wacky and principal financial officer mobile Spinotti.
Speaker Change: Earlier today I haven't you released financial results for the quarter ended March 31, 2020 for a copy of the release is posted on the ovens your website under Investor Relations.
Matthew Kreps: Earlier today, Avinger released its plans results for the quarter ended March 31, 2024. A copy of the release is posted on the Avinger website under Investor Relations. Before we begin, I'd like to remind you that management will make statements during this call that are forward-looking statements within the meaning of federal securities laws, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Therefore, any statements contained in this call that are not statements of historical fact should be deemed to be forward-looking statements.
Speaker Change: Before we begin I'd like to remind you that management will make statements. During this call that include forward looking statements within the meaning of federal Securities laws, which are made pursuant to the safe Harbor provisions of the private Securities Litigation Reform Act of NIS 95.
Speaker Change: Any statements contained in this call that are not statements of historical fact should be deemed to be forward looking statements. All forward looking statements, including without limitation, our future financial expectations and expected timing for commercial launch products and pause within the FDA are based upon our current estimates and various assumptions.
Matthew Kreps: All forward-looking statements, including without limitation our future financial expectations and the expected timing for the commercial launch of products and funds within the FDA, are based upon our current estimates and various assumptions. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements. Accordingly, you should not place undue reliance on these statements. For a list and description of the risks and uncertainties associated with our business, please see our Form 10-K and 10-Q filings with the Securities and Exchange Commission.
Speaker Change: These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward looking statements.
Speaker Change: Accordingly, you should not place undue reliance on these statements for a list and description of the risks and uncertainties associated with our business. Please see our Form 10-K, and 10-Q filings with the Securities and Exchange Commission.
Speaker Change: I haven't heard disclaims any intention or obligation, except as required by law to update or revise any financial projections or forward looking statements, whether because of new information future events or otherwise.
Matthew Kreps: Avinger disclaims any intention or obligation, except as required by law, to update or revise any financial projections or forward-looking statements, whether because of new information, future events, or otherwise. Today's presentation will include reference to non-GAAP financial measures, such as adjusted EBITDA. Reconciliation of these non-GAAP financial measures to the most comparable GAAP financial measures is available in the earnings release, which can be found on Avinger's website. And with that, I'd like to now turn the call over to Jeff. Thank you.
Today's presentation will include reference to non-GAAP financial measures such as adjusted EBITDA reconciliation of these non-GAAP financial measures to the most comparable GAAP financial measures is available within the earnings release, which can be found on <unk> website.
Jeff: What I'd like to now turn the call over to Jeff. Thank you.
Jeff: Thank you, Matt and good afternoon, and thank you all for joining us.
Jeffrey M. Soinski: Thank you, Matt. Good afternoon, and thank you all for joining us. Along with continued progress in our peripheral business, we had two exciting events in the first quarter that will provide significant new opportunities for Avinger as we move our company forward. In March, we announced a strategic partnership with Xilox Tunbridge, which opens a pathway for the introduction of our image-guided devices to the vast and growing Greater China market. During the first quarter, we also made exciting progress in the development of our first coronary product, initiating Phase III verification and validation studies for our proprietary CTO crossing device as we prepare for filing an IDE submission with the FDA later this year, starting with our new strategic partnership.
Jeff: Along with continued progress in our peripheral business, we had two exciting events in the first quarter that will provide significant new opportunities rather than here as we move our company forward.
Jeffrey M. Soinski: Xylox Tundrage is a fully integrated medical device company and a leader in the peripheral vascular and neurovascular markets in China. Since their founding in 2012, Xilox has developed and launched 36 products into the Greater China Interventional Market. They maintain a state-of-the-art manufacturing facility at their headquarters in Hangzhou, China, and are certified to the ISO 1345-2016 International Quality Standards. Under the terms of an equity financing agreement, Zilox will invest up to $15 million into Avinger through the purchase of preferred and common stock in two tranches. The first $7.5 million tranche was funded in March.
Jeff: In March we announced a strategic partnership with Xylogic, Tonbridge, which opens a pathway for the introduction of our image guided devices to the vast and growing greater China market during.
Jeff: During the first quarter. We also made exciting progress in the development of our first coronary product initiating phase III verification and validation studies for our proprietary CTO crossing device as we prepare for filing in I D E submission with the FDA later this year.
Jeffrey M. Soinski: Second tranche $7.5 million equity investment will be funded upon achieving key milestones, including successfully registering Xilox as a manufacturer of Avinger's products with the USFDA and Avinger achieving $10 million in aggregate revenue over four consecutive quarters. Under the terms of a license and technology transfer agreement, Xilox has exclusive rights to distribute and manufacture Avinger's proprietary image-guided devices in the Greater China region, including Mainland China, We are supporting Xilox in its regulatory process as they prepare for registration of the Avinger products in China.
Jeff: Starting with our new strategic partnership with <unk>.
Jeff: Like to Tunbridge as a fully integrated medical device company and a leader in the peripheral vascular and neurovascular markets in China.
Jeff: Since their founding in 2012, Lilacs has developed and launched 36 products into the greater China interventional markets there.
Lilacs: Maintain a state of the art manufacturing facility at their headquarters in Hong Zhao, China and are certified to the ISO 13, 45, 2016 international quality standard.
Lilacs: Under the terms of an equity financing agreement lilacs will invest up to $15 million of new avid you're through the purchase of preferred and common stock in two tranches.
Lilacs: The first $7 $5 million tranche was funded in March the SEC.
Speaker Change: <unk> tranche seven $5 million equity investment will be funded upon achieving key milestones, including successfully registering xylogics as a manufacturer of avenue's products with U S FDA and avon's, you're achieving $10 million in aggregate revenue over four consecutive quarters.
Under the terms of a license and technology transfer agreement.
Speaker Change: <unk> has exclusive rights to distribute manufacture avon's, there's proprietary image guided devices in the greater China region, including mainland, China, Hong Kong, Macau and Taiwan.
Zilog: We are supporting Zilog and their regulatory process as they prepare for registration of the Avon's your products in China.
Jeffrey M. Soinski: Following regulatory clearance, Avinger will sell products to Xilox for their initial product launch until such time as Xilox has established its own manufacturing capability and gained regulatory authorization for manufacturing Avinger products for the Chinese market. Sales of Avinger products in the Xilox territory will be royalty-bearing to Avinger.
Zilog: Boeing regulatory clearance Avon's, you will sell products to XI locks for their initial product launch until such time as zilog cause established their own manufacturing capability and gained regulatory authorization for manufacturing Avon's your products for the China markets.
Zilog: Sales of Avon's your products in those dialogues territory will be royalty bearing to average or.
Jeffrey M. Soinski: With more than 130 employees in sales and marketing and an extensive distribution network, VILOX is extremely well qualified to distribute Avinger products in the greater China region. Once Xylox has established its manufacturing capability and been successfully registered as a manufacturer of Averager's products with the US FDA, we will have the option to source finished products from Xylox on a cost-plus basis. We believe this could provide an opportunity for Avinger to reduce the cost of goods sold, improve gross margin, and reduce facility and related overhead expense in the future.
Zilog: With more than 130 employees in sales and marketing and an extensive distribution network <unk> is extremely well qualified to distribute avon's your products in the greater China region.
Zilog: Once dialogues as established their manufacturing capability, and then successfully registered as a manufacturer of averages products with the U S. F. D. A we will have the option to source finished product from dialogues on a cost plus basis. We believe this could provide the opportunity for avinger to reduce cost of goods sold improved.
Zilog: Gross margin and reduced facility and related overhead expense in the future.
Zilog: Our collaboration with Xilinx is off to a great start and we're excited about the strategic benefits. This relationship brings to average or strengthening our balance sheet, providing a pathway to vast new markets and creating the opportunity to improve our gross margin and cost structure over time.
Jeffrey M. Soinski: Our collaboration with Xilox is off to a great start, and we're excited about the strategic benefits this relationship brings to Avinger, strengthening our balance sheet, providing a pathway to vast new markets, and creating the opportunity to improve our gross margin and cost structure over time. Now turning to our Coronary Development Program, we are very excited about the progress we are making in the development of our first coronary device, an image-guided CTO crossing system based upon our proven technology platform, which we believe provides the opportunity to redefine a large and underserved market, following an extensive design and development process and multiple rounds of animal studies and cadaver heart studies with KOL physicians, experts in coronary CTO crossing and OCT intravascular We have completed Phase 2 design selection and have advanced our development program to Phase 3 in the product development process, pending the successful completion of the required verification and validation tests.
Jeffrey M. Soinski: We anticipate being in a position to file an IDE submission with the FDA in the third quarter of this year to allow for the initiation of a clinical study following approval. Crossing chronic total occlusions in the coronary arteries can be complex, time-consuming, and have high failure rates. By leveraging our proprietary image-guided technology, we believe we can provide physicians with a superior, simplified, and more predictable solution for crossing coronary CTOs, with the need for less radiation exposure and contrast media use.
Zilog: Now turning to our coronary development program.
Zilog: We're very excited about the progress we're making in the development of our first coronary device and image guided CTO crossing system based upon our proven technology platform, which we believe provides the opportunity to redefine a large and underserved market.
Zilog: Following an extensive design and development process and multiple rounds of animal studies, and cadaver heart studies with Kols and physicians expert in coronary CTO crossing in the O C T Intravascular imaging.
Zilog: We have completed phase two design selection and have advanced our development program to phase three and the product development process.
Speaker Change: Pending successful completion of the required verification and validation testing, we anticipate being in a position to file an IDE submission with the FDA in the third quarter of this year to allow for initiation of a clinical study following approval.
Speaker Change: Crossing chronic total occlusions in the coronary arteries can be complex time consuming and have high failure rates.
Speaker Change: By leveraging our proprietary image guided technology. We believe we can provide physicians with a superior simplified and more predictable solution for crossing coronary C. T OS.
Speaker Change: With the need for less radiation exposure and contrast media usage.
Jeffrey M. Soinski: Our coronary system features a low-profile, four-french catheter design that combines real-time OCT guidance with precise control and steerability to facilitate a nanograde approach, which we expect to significantly reduce procedure times and improve crossing success rates. Like our peripheral catheters, our coronary device incorporates a precise measurement capability to help physicians properly size balloons or stents prior to placement, which is critical for optimal outcomes. We think our solution can accomplish this with less reliance on specialty wires, support catheters, recanalization devices, and reentry devices, while also limiting x-ray radiation exposure and usage of iodine-containing contrast dye, which can pose various health risks. We are confident our combination of onboard image guidance and precise control within the vessel will support a robust safety profile during clinical practice.
Speaker Change: Our coronary system features a low profile four French catheter design that combines real time O C. T guidance with precise control and sterile steer ability to facilitate man a great approach, which we expect to significantly reduce procedure times and improve crossing success rates like our peripheral catheter.
Speaker Change: Our coronary device incorporates a precise measurement capability to help physicians properly size balloons stents prior to placement, which is critical for optimal outcomes.
Speaker Change: We think our solution can accomplish this with less reliance on specialty wires support catheters, we cannibalization devices and reentry devices, while also limiting X ray radiation exposure and usage of iodine containing contrast di which can pose various health risks we are confident our combination of all.
Speaker Change: Onboard image guidance and precise control within the vessel will support a robust safety profiles during clinical practice.
Speaker Change: We believe our coronary CTO crossing device will preside at present, a highly compelling economic value propositions, reducing crossing time contrast media usage and the need for certain accessory devices would result in significant cost savings for the hospital system. In addition, our coronary system.
Jeffrey M. Soinski: We believe our coronary CTO crossing device will present a highly compelling economic value proposition. Reducing crossing time, contrast media usage, and the need for certain accessory devices would result in significant cost savings for the hospital system.
Jeffrey M. Soinski: In addition, our coronary system would not only access existing high-value reimbursement codes for CTO crossing, but it would also access existing codes for coronary OCT diagnostic imaging immediately upon FDA clearance. We think this makes great sense from both a clinical and business perspective, and we're excited to provide further updates as we advance this revolutionary product to IDE filing later this year. During the first quarter, we also continued to make progress with our peripheral business.
Speaker Change: With not only access existing high value reimbursement codes for CTO crossing it would also access existing codes for coronary octu diagnostic imaging immediately upon FDA clearance.
Speaker Change: We think this makes great sense from both a clinical and business perspective, we're excited to provide further updates as we advance this revolutionary product dry D. Filing later this year.
Speaker Change: During the first quarter. We also continued to make progress with our peripheral business, our new sales representatives and clinical specialists have completed their on boarding and are gaining clinical proficiency with our devices as they build their sales pipelines and advance new accounts and users through the sales process.
Jeffrey M. Soinski: Our new sales representatives and clinical specialists have completed their onboarding and are gaining clinical proficiency with our devices. [inaudible] Our new Tiger IST CTO crossing device, launched in the second half of last year, continues to increase market penetration and support the growth of our CTO business. And we continue to gain valuable clinical experience with our new Pantheras-LV large vessel atherectomy device as we prepare for commercial expansion later this year. At this point, I'd like to turn the call over to Nabeel Subainati, our Principal Financial Officer and Accounting Officer, to take us through the financial results, and then I'll return for Q&A. Thank you, Jeff.
Speaker Change: Our new Tiger I S. T CTO crossing device launched in the second half of last year continues to increase market penetration and support the growth of our CTO business.
Speaker Change: And we continue to gain valuable clinical experience with our new Pantera L. The large vessel atherectomy device as we prepare for commercial expansion later this year.
Speaker Change: At this point I'd like to turn the call over to Neville Spinotti, Our principal financial officer, and accounting officer to take us through the financial results and then I'll return for Q&A Bill. Thank.
Neville Spinotti: Thank you Jess.
Nabeel P. Subainati: Total revenue was $1.9 million for the first quarter of 2024, compared with $1.9 million in the fourth quarter of 2023 and $1.9 million in the first quarter of 2020. Gross margin for the first quarter of 2024 was 18%, compared to 20% in the fourth quarter of 2023 and 34% in the first quarter of 2023. The change in gross margin primarily reflects lower production activity during the quarter as we continue to optimize inventory levels while conserving cash expenditure.
Neville Spinotti: Other revenue was $1 9 million for the first quarter of 2024.
Neville Spinotti: Paired with $1 9 million.
Neville Spinotti: In the fourth quarter of 2023, and $1 9 million in the first quarter of 2023.
Margins for the first quarter of 2024 was 18% compared with 20% in the fourth quarter of 2023 and 34% in the first quarter of 2023. The change in gross margin primarily reflects lower production activity during the quarter as we continued to optimize inventory levels, while conserving cash expenditures.
Neville Spinotti: Operating expenses for the first quarter of 2024 were $5 $5 4 million.
Nabeel P. Subainati: Operating expenses for the first quarter of 2024 were $5.4 million. (Inaudible) The increase in operating expenses primarily relates to the increase in sales headcount and expenses related to the Xilox-Stonebridge transaction, which Jeff discussed earlier, and other corporate activities. Net loss and comprehensive loss for the first quarter of 2024 was $5.5 million, compared with $5.0 million in the fourth quarter of 2023 and $4.6 million in the first quarter of 2020. Adjusted EBITDA, as defined under our non-GAAP financial measures provided in today's press release, was a loss of $3.9 million, compared to a loss of $4.3 million in the fourth quarter of 2023 and a loss of $3.9 million For more information regarding non-GAAP financial measures, please see the non-GAAP financial measures and reconciliation of non-GAAP measures to the nearest GAAP measure provided in the tables in today's press release.
Compared to the $5 million in the fourth quarter of 2022, and $4 $9 million in the first quarter of 2023.
The increase in operating expenses, primarily related to the increase in sales head count.
Neville Spinotti: And expenses related to the Zilog, Stonebridge transaction, which Jeff discussed earlier and other corporate activities.
Neville Spinotti: Net loss and comprehensive loss for the first quarter of 'twenty 'twenty, four was $505 million compared with $5 million in the fourth quarter of 'twenty 'twenty, four 2023 and $4 $6 million in the first quarter of 2023.
Neville Spinotti: Adjusted EBITDA as defined under our non-GAAP financial measures is provided in today's press release was a loss of $3 $9 million compared to a loss of $4 $3 million in the fourth quarter of 2023, and a loss of $2 $9 million in the first quarter of 2023.
Neville Spinotti: For more information regarding non-GAAP financial measures. Please see the non-GAAP financial measures and a reconciliation of non-GAAP measures to the nearest GAAP measure are provided in the tables in today's press release.
Nabeel P. Subainati: Cash and cash equivalents totaled $7.2 million as of March 31. Inmark, of this year, CRG Partners, the primary holder of Avinger debt and preferred equity, exchanged its Series A preferred stock with an aggregate liquidation preference of $61 million for new Series A1 preferred stock with a value of $10 million. The new Series A1 preferred stock is convertible at a conversion price of $3.66 per share and carries no liquidation preference or dividend preference.
Speaker Change: Cash and cash equivalents totaled $7 $2 million as of March 31st.
Speaker Change: In March.
Speaker Change: This years. He argued partner who is the primary holder of Avon's your debt and preferred equity exchange the series a preferred stock with an aggregate liquidation preference of $61 million for new series, a one preferred stock with a value of $10 million.
Speaker Change: The new series, a one preferred stock is convertible at a conversion price of $3 66 per share and carries no liquidation preference or dividend preference.
Nabeel P. Subainati: Additionally, CRG extended principal payments on Avinger's debt from the first quarter of 2024 to the first quarter of 2027, with interest payments accruing during this time. At this point, I'd like to turn the call back to Jeff for Q&A. Thanks, Nabeel.
Speaker Change: Suddenly CRD extended principal payments on avon's debts in the first quarter of 2024 to the first quarter of 2027 with interest payments occurring during this time.
Jeff: At this point I'd like to turn the call back to Jeff for Q&A.
Bill: The Bill we're excited about our new partnership with dialogues Tonbridge in the rapid progress, we're making in the development of our first coronary product.
Jeffrey M. Soinski: We're excited about our new partnership with Xylox Tunbridge and the rapid progress we're making in the development of our first coronary product. We're encouraged by the outstanding clinical outcomes we see physicians deliver with our peripheral devices and cath labs across the country every day, and we appreciate the dedicated efforts of our team as they remain committed to our mission of radically changing the way vascular disease is treated. At this point, we'd be happy to take your questions.
Speaker Change: We're encouraged by the outstanding clinical outcomes, we see physicians deliver with our peripheral devices in cath labs across the country every day and we appreciate the dedicated efforts of our team as they remain committed to our mission of radically changing the way vascular disease is treated.
Speaker Change: At this point, we'd be happy to take your questions.
Speaker Change: Okay.
Speaker Change: Thank you at this time, we would be conducting our question and answer session. If you'd like to ask a question. Please press star one on your telephone keypad.
Operator: Thank you. At this time, we will be conducting our question and answer session. If you would like to ask a question, please press star one on your telephone key. A confirmation tone will indicate your line is in the queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star key. One moment, please, while we poll for questions. Thank you. We have a question on the line from Swayampakula Ramakanth from H.C. Wainwright. Your line is live.
Speaker Change: A confirmation tone will indicate your line is in the queue. You May press star two if you'd like to remove your question from the queue.
Speaker Change: And for participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.
Speaker Change: One moment, please while we poll for questions.
Speaker Change: Thank you.
Speaker Change: We have a question on the line.
Speaker Change: From ceramic cooler Rama Khan from H C. Wainwright your line is life.
Swayampakula Ramakanth: Thank you.
Swayampakula Ramakanth: Good afternoon, Jeff and Nabeel. A couple of quick questions. The first one is about the new partnership that you're talking about with Xylox, Stonebridge.
Swayampakula Ramakanth: Good afternoon, Jeff and Bill a couple of quick questions on the first one is on the announced a new partnership that you were talking about the dogs that locks Tonbridge.
Speaker Change: So I'm just like to understand.
Swayampakula Ramakanth: So I'd just like to understand when you anticipate, you know, commercialization of products? In China, how long do you think that they would take to get products registered? So that they can start commercializing, you know, the stuff which you're producing here before they are able to manufacture themselves over there.
Speaker Change: When do you anticipate.
Speaker Change: Now commercialization of product.
Speaker Change: In China, how long do you think that they would take.
Speaker Change: To get products or they just start.
Speaker Change: So that they can start commercializing stuffed with share producing here.
Before they're able to manufacture themselves over there.
Jeffrey M. Soinski: Thanks for the question, RK. So, yes, we are very, very pleased with how quickly and how engaged Xilox is in not only building their internal manufacturing capability but also developing all of the documentation required to support the registration of our products in China. We actually got a little head start on that as we were finalizing our agreements. And so it is a priority both in their organization as well as in ours.
RK: Thanks for the question RK. So yes, we are.
RK: Very very pleased with how quickly and how engaged.
RK: The dialogue is in not only building their internal manufacturing capability, but also.
RK: Developing all of the documentation required to support the registration of our products in China, We actually got a little head start on that as we were finalizing our agreements and so it is a priority both in their organization as well as our organization now they control the timelines and theres much out of.
Jeffrey M. Soinski: Now, they control the timelines, and there's much out of their control as well, given that the Chinese regulatory system, just like the U.S. FDA, will move at its own pace. However, based on our projections, we expect that it is realistic that registration could be achieved before the end of 2025. And we expect that the manufacturing capability at Xilox can come online and be validated within that timeframe as well. So, again, a very productive and focused effort that we think can bear fruit in 2025.
RK: Their control as well given that the the Chinese regulatory system, just like the U S. F. D. A will will move at their own pace. However, based on our projections. We expect that it is realistic that registration could be achieved by prior to the.
RK: End of 2025, and we expect that the manufacturing capability of dialogues can come online and be validated within that timeframe as well. So again, a very productive and and a focused effort that we think can bear fruit in 2025.
Okay.
Swayampakula Ramakanth: So, as you're waiting for the product to be... Swayampakula Ramakanth, Matthew Kreps, Nabeel Subainati, Avinger Subainati, Nabeel Subainati, So, since you have the CEA mark there, is it easier to get started now there, or how does that work in China? I mean in Germany.
Speaker Change: So as you're waiting for the product to be.
Speaker Change: Commercialized in China, you were also talking about product that can be commercialized in Iraq.
Speaker Change: Hum.
Speaker Change: So since you.
Speaker Change: Since you have the CE Mark there is it easier to get started now there or how does that work in China.
Speaker Change: I mean in Germany.
Speaker Change: Germany I'm sorry.
Jeffrey M. Soinski: So, in Germany, we, as you know, currently market our products under the CE Mark, and we also distribute our products in other markets as well, but our primary European market is Germany given the reimbursement structure and the relationships we have with certain KOL physicians. So, we don't see an opportunity for, you know, incremental revenue with our products beyond the growth that, you know, that our team is focused on driving in Europe. However, there are certain products that Zilox has that have the CE marking, and we have the ability to engage with them to see if it would be suitable for us to distribute those products in our existing accounts in Germany.
Speaker Change: Yeah. So in Germany, we are as you know currently market our products under CE Mark.
Speaker Change: And we also distribute our products and in other markets as well.
Speaker Change: But our primary European market is Germany, given the reimbursement structure and the relationships, we have with certain kols and physicians.
Speaker Change: So we don't see an opportunity for incremental revenue.
Speaker Change: With our products beyond the growth that you know that our team is focused on driving in Europe. However, there are certain products that dialogue has that they have that have CE, marking which we have the ability to engage with them to see if it would be suitable for.
Speaker Change: For us to distribute those products into our existing accounts in Germany. The timeframes on that would not require a new regulatory registration.
Jeffrey M. Soinski: The timeframes on that would not require a new regulatory registration, but we are prioritizing getting them up to speed and their regulatory clearance efforts underway for China and also developing their manufacturing capability, which we see as the larger opportunity.
Speaker Change: But we are prioritizing getting them up to speed and their regulatory clearance efforts underway for China and also developing their manufacturing capability, which we see as the larger opportunity.
Swayampakula Ramakanth: Yeah, yeah, understood. And then in terms of... And what you're doing here in the U.S. regarding the IDE submission, you know, that you're anticipating, and especially for the CTL crossing system. In the third quarter, what else needs to get done for you? and for you to submit that application.
Speaker Change: Yeah Yeah.
Speaker Change: And then.
Speaker Change: In terms of.
Speaker Change: And what you are doing here in the U S regarding the IDE submission.
Speaker Change: And our doctor and anticipating them.
Speaker Change: And especially about the CTO crossing system.
Speaker Change: Hum.
Speaker Change: In the third quarter, what else needs to get done you know before you do.
Speaker Change: Hum.
Speaker Change: I'm sorry, you just supplement that application.
Jeffrey M. Soinski: Yes, so really just the basis of an IDE submission would require that you complete your phase 3 verification validation testing, which would include, you know, DVT and DVAL testing. We have a final design, and we're in the process of doing that full suite of biocompatibility testing, having the clinical study design and your initial sites identified as well as any GL GMP animal studies that are required, and so we're in that process now really on all of those things.
Speaker Change: Yeah, So you know it.
Speaker Change: Really just the the are the basis of a of an I D. E submission would require that you complete your phase III verification validation testing, which would include you know D V T and D. Var testing, we have the final design and we're in process on that full suite of biocompatibility.
Speaker Change: <unk> testing, having the clinical study design and your initial sites are identified.
Speaker Change: As well as the.
Speaker Change: As well as any G. L. G M P animal studies that are required.
Speaker Change: And so we're in that process now really on all of those things as you know we completed design selection AR.
Jeffrey M. Soinski: As you know, we completed design selection at the end of 2023, so we've been into this now for most of this year and feel like we are in good shape. Obviously, we have to complete all the testing and get the desired results, and that could impact timing, but based on what we know now, we feel like we're in good shape to achieve our objective of filing in the U.S. prior to the end of the third quarter.
Speaker Change: At the end of 2023.
Speaker Change: So we haven't been into this now for most of this year and feel that we are in good shape. Obviously, we have to complete all the testing and get the results the desired results and that good timing, but based on what we know now we feel like we're in good shape to achieve our objective of filing in the.
Speaker Change: Prior to the end of the third quarter.
Speaker Change: Okay.
Swayampakula Ramakanth: Thank you very much; thanks for taking all my questions.
Speaker Change: Fantastic.
Speaker Change: Then thank you very much thanks for taking all my questions.
Jeffrey M. Soinski: Thank you. Thank you, R.K.
RK: Thank you thank you RK.
Operator: Thank you. As we have no further questions in the queue at this time, I will hand it back to Mr. Soinski for any closing comments he may have.
RK: Thank you.
Speaker Change: We have no further questions in the queue at this time I will hand, it back to Mr. Suminski for any closing comments you may have.
Mr. Suminski: Thank you and thank you all for joining our call. This afternoon, we very much appreciate your interest in our company and look forward to reporting our further progress in the coming quarters have a good evening.
Jeffrey M. Soinski: Thank you, and thank you all for joining our call this afternoon. We very much appreciate your interest in our company and look forward to reporting further progress in the coming quarters. Have a good evening.
Mr. Suminski: Thank you.
Operator: Thank you. This concludes today's call, and you may disconnect your lines at this time, and we thank you for your participation.
Speaker Change: This concludes today's call and you may disconnect your lines at this time and we thank you for your participation.