Financial Data and Key Metrics Changes - The company reported a 33% year-over-year increase in bioenvelope revenue for the quarter, reaching a run rate of approximately $14 million [10] - Elupro revenue grew 49% sequentially, now accounting for 68% of total bioenvelope revenue [10][12] - Adjusted gross margin improved to 62.4%, up over four percentage points from the previous year [34] - The company ended Q2 with $8.5 million in cash, indicating a stable financial position [36] Business Line Data and Key Metrics Changes - Elupro's sales per account are 130% higher than the previous product, Kangaroo, reflecting greater utilization [13] - The cardiovascular patch products generated over $700,000 in revenue for a partial quarter, more than double the previous distributor's revenue [32] - SimpliDerm revenue decreased to $2 million, indicating potential for improvement in that product line [33] Market Data and Key Metrics Changes - The breast reconstruction market is valued at $1.5 billion in the U.S., with biologics accounting for 65% of device-related spending [20] - Approximately 317,000 women are diagnosed with invasive breast cancer annually, leading to significant market potential for reconstruction products [19] Company Strategy and Development Direction - The company aims to scale Elupro by increasing the number of VAC approvals and GPO coverage [38] - The NXT 41 platform is positioned to address significant unmet medical needs in breast reconstruction, with anticipated market launch in 2026 [25][40] - The company is exploring strategic opportunities that may positively impact cash position in the near future [36][41] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory of Elupro, citing predictable ordering patterns and strong hospital partnerships [46][50] - The company is focused on addressing the high complication rates in breast reconstruction procedures, emphasizing the need for innovative solutions [22][23] Other Important Information - The company has settled 97 out of 110 lawsuits related to a past product recall, significantly reducing future expenses and legal overhang [29][30] - The company is actively working on business development transactions, with expectations for announcements in the near future [41] Q&A Session Summary Question: What are the bottlenecks in the Elupro launch? - Management noted initial production challenges but emphasized that operations have now stabilized, allowing for efficient scaling [45][46] Question: Can you clarify the NXT 41 launch timeline? - The base matrix is expected to launch in 2026, followed by the drug-eluting version in 2027, with a focus on regulatory strategy [52][56] Question: How can gross margins be maintained or expanded? - Management highlighted opportunities for margin improvement across all business segments, particularly in Elupro and cardiovascular products [64] Question: What level of clinical evidence is needed for NXT 41? - The company plans to follow a similar regulatory pathway as Elupro, focusing on generating clinical data for marketing purposes [67]

Financial Data and Key Metrics Changes - The company reported a total revenue of $6 million for Q1 2025, down from $7 million in the previous year but up 10% sequentially from Q4 2024 [33][34][38] - The adjusted gross margin was 54.8%, slightly down from 55.2% year-over-year, but expected to improve with operational efficiencies [36][37] - Adjusted EBITDA for the quarter was $3.3 million, an improvement from $4.5 million in the previous year [37] Business Line Data and Key Metrics Changes - The BioEnvelope division generated $3.1 million in revenue, representing a 31% year-over-year growth and a 16% sequential increase [33][34] - Simploderm revenue was $2.6 million, down from $3.6 million year-over-year but up 13% from Q4 2024 [34] - The cardiovascular products division reported $300,000 in sales, with expectations for significant growth as the company takes back control of sales efforts [35] Market Data and Key Metrics Changes - The company has secured contracts with 125 hospitals actively ordering Elupro, with an additional 130 Value Analysis Committees (VACs) in process [11][12] - The partnership with Boston Scientific has expanded the sales force to 900 representatives, enhancing market penetration [18][20] Company Strategy and Development Direction - The primary focus is on driving top-line growth for Elupro through expanding VAC and Group Purchasing Organization (GPO) coverage [41] - The company plans to explore strategic alternatives for its Simploderm product line and advance its drug-eluting biologic pipeline [42][43] - A new facility in Gaithersburg, Maryland, is expected to alleviate production bottlenecks and reduce costs [22][23] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about a strong second half of 2025, driven by the successful launch of Elupro and the partnership with Boston Scientific [13][41] - The company is focused on increasing production capacity and lowering costs to achieve gross margins in the mid-70% range [42] Other Important Information - The company received an Edison Award for innovation in post-surgical recovery for Elupro [27] - A real-world clinical study has begun, with the first patients enrolled at UCSD, aimed at gathering clinical outcome data [27][61] Q&A Session Summary Question: How have relationships with physicians gone in accounts selling with Boston Scientific? - Management noted that adoption patterns for Elupro are positive, with initial orders often leading to higher subsequent orders as physicians experience the product [49][50] Question: What is the current manufacturing capacity without the Gaithersburg facility? - Current manufacturing capacity allows for approximately $140 million in Elupro revenue, but without the antibiotic disc expansion, it is constrained to $25 million to $30 million [54] Question: What is the expected cash burn profile going forward? - The cash flow statement is expected to show operational cash flow around $4 million to $5 million after Q2, following the settlement of litigation costs [56][57] Question: How will the registry study support commercial conversions? - The registry study is anticipated to be more impactful in the second half of next year, aiding in regulatory submissions and enhancing the VAC process [60][61] Question: What is the expected revenue growth for Elupro compared to Kangaroo? - Elupro is projected to reach approximately $200 million in U.S. revenue at maturity, significantly surpassing Kangaroo's $10 million at maturity [63][64]

Financial Data and Key Metrics Changes - The company reported a total revenue of $6 million for the first quarter, down from $7 million a year ago but up 10% sequentially from the previous quarter [33][34][38] - The adjusted gross margin was 54.8%, slightly down from 55.2% year over year, but expected to improve as efficiencies in manufacturing are realized [36][37] - Adjusted EBITDA for the quarter was $3.3 million, an improvement from $4.5 million in the previous year [37] Business Line Data and Key Metrics Changes - The BioEnvelope division generated $3.1 million in revenue, representing a 31% year-over-year growth and a 16% sequential increase [33][34] - Simploderm revenue was $2.6 million, down from $3.6 million a year ago but up 13% from the previous quarter [34] - The cardiovascular products division reported $300,000 in sales, with expectations for significant growth as the company takes back control of sales efforts [35] Market Data and Key Metrics Changes - The company has secured Value Analysis Committee (VAC) approvals from 125 hospitals, with an additional 130 VACs in process [11][12] - The partnership with Boston Scientific has expanded the sales force to over 900 representatives, enhancing market reach [18][20] Company Strategy and Development Direction - The primary focus is on driving top-line growth for Elupro through expanding VAC and Group Purchasing Organization (GPO) coverage [41] - The company plans to explore strategic alternatives for its Simploderm product line [42] - There is an ongoing effort to advance the drug-eluting biologic pipeline for reconstructive surgery [44] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about a strong second half of 2025, driven by the successful launch of Elupro and the partnership with Boston Scientific [13][41] - The company is focused on increasing production capacity and lowering costs for Elupro, targeting gross margins in the mid-70% range [42][43] Other Important Information - The company opened a new facility in Gaithersburg, Maryland, to enhance manufacturing capacity for critical components, which is expected to reduce costs [22][23] - The company received an Edison Award for innovation in post-surgical recovery for Elupro [27] Q&A Session Summary Question: How have relationships with physicians gone in those cases with Boston Scientific? - Management noted that adoption patterns for Elupro are positive, with initial orders often leading to higher subsequent orders as more physicians in practices begin to use the product [49][50] Question: What is the current manufacturing capacity without the Gaithersburg facility? - Current manufacturing capacity allows for approximately $140 million in Elupro revenue, but without the new facility, capacity would be constrained to $25 million to $30 million [54] Question: What should be expected regarding cash burn going forward? - Cash flow from operations is expected to stabilize around $4 million to $5 million after Q2, following the settlement of litigation costs [56][57] Question: How will the registry study data support commercial conversions? - The data from the registry study is anticipated to be more impactful in the second half of next year, aiding in regulatory submissions and enhancing the VAC process [60][61] Question: What is the expected revenue for Elupro as it matures? - Elupro is projected to reach approximately $200 million in U.S. revenue at maturity, significantly surpassing the previous product, Kangaroo [63][64]

Financial Data and Key Metrics Changes - The company reported Q1 2025 revenue of $6,000,000, down from $7,000,000 in Q1 2024 but up 10% sequentially from Q4 2024 [33][34][36] - Adjusted gross margin for Q1 2025 was 54.8%, slightly down from 55.2% in the previous year, with expectations for improvement as efficiencies are realized [35][36] - Adjusted EBITDA for Q1 2025 was $3,300,000, an improvement from $4,500,000 in the previous year [37] Business Line Data and Key Metrics Changes - The BioEnvelope division generated $3,100,000 in revenue, representing a 31% year-over-year growth and a 16% sequential increase [10][33] - Simploderm revenue was $2,600,000, down from $3,600,000 year-over-year but up 13% from Q4 2024 [34] - Cardiovascular products division reported $300,000 in sales, with expectations for significant growth as the company takes back control of sales [35][36] Market Data and Key Metrics Changes - The company has secured contracts with 125 hospitals actively ordering Elupro, with an additional 130 Value Analysis Committees (VACs) in process [12][13] - The partnership with Boston Scientific has expanded the sales force to 900 representatives, enhancing market penetration [18][20] Company Strategy and Development Direction - The primary focus is on driving top-line growth for Elupro through expanding VAC and Group Purchasing Organization (GPO) coverage [41] - The company plans to explore strategic alternatives for its Simploderm product line and advance its drug-eluting biologic pipeline for reconstructive surgery [42][44] - The new Gaithersburg facility will enhance production capacity and reduce costs by manufacturing critical components in-house [22][23] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about a strong second half of 2025, driven by the successful launch of Elupro and the partnership with Boston Scientific [14][41] - The company is focused on increasing production capacity and lowering costs to achieve gross margins in the mid-seventy percent range [42] Other Important Information - The company received an Edison Award for innovation in post-surgical recovery for Elupro [27] - A real-world clinical study has commenced, with the first patients enrolled at UCSD, aimed at gathering clinical outcome data [27][60] Q&A Session Summary Question: How have relationships with physicians gone in those cases with Boston Scientific? - Adoption patterns for Elupro show that initial orders are often followed by higher subsequent orders, indicating strong physician interest and usage [48][50] Question: What is the current manufacturing capacity without the Gaithersburg facility? - Current manufacturing capacity allows for approximately $140,000,000 in Elupro revenue, but without the antibiotic disc expansion, it is limited to $25,000,000 to $30,000,000 [53] Question: What should be expected regarding cash burn going forward? - Cash flow from operations is expected to stabilize around $4,000,000 to $5,000,000 as litigation settlements conclude [55][56]