# Presentation: 007183

## Novian Health’s Response to FDA’s Request for Comments

- Potential for a Registry of Breast Cancer Treatment Using Thermal Ablation Devices
- Docket No. FDA-2008-N-0280

## Cancer-related Thermal Ablation Registries

**F**ibro**A**denoma **C**ryoablation **T**reatment (FACT)
**C**ryo **O**n-**L**ine **D**atabase (COLD) – prostate
**H**igh **I**ntensity **F**ocused **U**ltrasound (HIFU) Prostate Cancer Treatment Clinical Registry
**A**merican **B**reast **L**aser **A**blation **T**herapy **E**valuation (ABLATE) – *in planning stages*

## Standardized Registries Can Provide Data on Margin Status & Re-treatments

- A registry is an efficient method to collect larger data sets over longer time periods on outcomes beyond recurrence.
- Thermal ablation procedures without subsequent excision can leverage advances in imaging technologies to demonstrate effectiveness.
- Standard practice is to obtain clear margins, often requiring a 2nd surgical procedure.
- 20-50% re-treatment rates cited at ASBS Conference, 4/08
- It is absolutely unacceptable to have tumor cells directly at the cut edge of the excised specimen.
- -Dowlatshahi K, Dieschbourg JJ. Shift in the surgical treatment of non-palpable breast cancer: tactile to visual. *Breast Cancer Online. *2005.
- -Aziz D, Rawlinson E, Narod SA, et al. The role of reexcision for positive margins in optimizing local disease control after breast-conserving surgery for cancer. *Breast J. *Jul-Aug 2006;12(4):331-337).
- -Singletary SE. Surgical margins in patients with early-stage breast cancer treated with breast conservation therapy. *Am J Surg. *Nov 2002;184(5):383-393).

## Our Technology:  NovilaseTM ILT Breast Therapy

- Interstitial Laser Therapy (ILT) - minimally invasive alternative to lumpectomy; uses stereotactic image guidance, 2 small (14G) needles and local anesthesia
- FDA clearance for fibroadenomas (May ‘07)
- 2 US sites currently fully functional & treating benign breast tumors (2 add’l sites trained)
- Patient registry **“ABLATE”** currently being implemented
- Malignant trial initiation planned for early ‘09

## ILT Clinical Experience

- ILT Breast Cancer Study:
- 70 procedures in 63 patients, 1, 3 & 6 mo follow-up, no serious AEs
- 65 procedures in malignant; 5 procedures in benign
- 56 patients had surgical excision + pathology
- Overall tumor ablation was 95% based on volume and 89% based on linear dimension
- 9 procedures in malignant without surgical excision
- Followed with x-ray and ultrasound; 77% showed no evidence of residual tumor
- 2.5-3.5cm zone of necrosis surrounded ablated tumor
- ILT is safe and effective for ablating breast tumors up to 2cm
- -Dowlatshahi K, Francescatti DS, Bloom KJ. Laser therapy for small breast cancers. *Am J Surg. *Oct 2002;184(4):359-363.
- -Dowlatshahi K, Dieschbourg JJ, Bloom KJ. Laser therapy of breast cancer with 3-year follow-up. *Breast J. *May-Jun 2004;10(3):240-243.
- -Dowlatshahi K, Dieschbourg JJ. Shift in the surgical treatment of non-palpable breast cancer: tactile to visual. *Breast Cancer Online. *2005.

## Our ABLATE Registry Goals are to:

- Monitor long term safety and efficacy of NovilaseTM Breast ILT in real world application by collecting large volumes of data
- Help refine, improve and/or validate best practices and breast tumor standards of care
- Report findings to the breast cancer community and public health authorities to support further research (transparency)
- Track tumor re-treatment and recurrence

## ABLATE Oversight

- Scientific
- Novian Health Scientific Advisory Board (comprised of national breast cancer specialists)
- Am Soc Breast Surgeons involvement is being considered
- Technical
- Alquest CRO (specializes in medical devices)
- Sponsorship/Funding
- Novian Health

## ABLATE Key Data Elements

- Patient demographics
- Medical history
- Tumor characteristics
- Equipment & device attributes
- Device application
- Imaging/guidance modalities
- Anesthesia
- Pathological dx
- Follow up appt results

- Adjuvant therapies
- Care path
- Clinical outcomes
- Treatment complications
- Recurrence, survival
- Adverse events
- Cosmetic satisfaction
- Pain rating
- Breast center code/info
- Patient volume at site

## Example of data collection form used in compiling, reporting and publishing  ABLATE patient registry data  ==>

- DRAFT

## Stakeholder Benefits:  Consistent and Reliable Reporting

- DRAFT

## Continued...

**Continued...**

- DRAFT

## Outcomes may be graphed, charted and mapped to illustrate trends and comparisons

*For illustration purposes only...*

## Case Study Example of a 7 Year Follow-up

|  | Tx (2000) | Week 1 | Month 1 | Month 3 | Month 6 | Year 1
(2001) | Year 2 (2002) | Year 3 (2003) | Year 4 (2004) | Year 5 (2005) | Year 6 (2006) | Year 7 (2007) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Pain | Minimal (local anes) | None | None | None | None | None | None | None | None | None | None | None |
| Cos-mesis |  | Light swell-ing |  |  | Excell-ent | Excell- ent | No 
scar | No scar | No scar | No scar | No scar | No scar |
| Size | 2 cm |  |  | Smaller by US & phys exam | 40% reduc-tion | Debris; no mass | Shrunk-en | Stable/scar-ified | Stable/scar-ified | Stable/scar-ified | Stable/scar-ified | Stable/scar-ified |
| Imag-ing | Stereo-guided;
CDUS |  | Xray & US | Xray & US | Xray & US | Xray & US | Xray & US: normal/necrotic | Xray & US: normal | Xray & US: normal | Xray & US: normal | Xray & US: normal | Xray & US: normal |
| Path | Pre-tx core needle biopsy |  |  | Needle core biopsy: necro-sis |  | Oily cyst aspir-ated |  |  |  |  |  |  |
| Palp-ability |  |  |  |  | Barely palp-able | Impal-pable | Impal-pable | Impal-pable | Impal-pable | Impal-pable | Impa-lpable | Impal-pable |

***Large volume long term tracking data can be charted and mapped***

## To be launched in Fall 2008...

**To be launched in Fall 2008...**

- Novian Health is interested in collaborating with the FDA and other clinical entities on thermal ablation registries.

## Who is Novian Health?

- Medical device company - Chicago, IL
- Developed, tested, and patented a minimally invasive procedure called NovilaseTM that uses ILT (controlled heating) for the ablation of breast tumors as an alternative to lumpectomy
- Mission:  To provide women with a minimally invasive alternative to lumpectomy
- For more info:  _[www.novianhealth.com](http://www.novianhealth.com/)_

## Guidance & Resources

- Kocgil OD, Baykal N. An integrated approach to breast diseases and breast cancer registry and research: BDRS as a web-based multi-institutional model. *Comput Biol Med. *Oct 2007;37(10): 1414-1425.
- Gliklich, RE, NA Dreyer, eds. ``Registries for Evaluating Patient Outcomes: A User's Guide.'' AHRQ Publication No. 07-EHC001-1. Rockville, MD: Agency for Healthcare Research and Quality. April 2007.
- Gliklich, RE, Dos & Don’ts for Designing Patient Registries.  *Outcome: Thompson Interactive & AHC Media LLC*, 2008.
- Goldberg, SN, et al. ``Image Guided Tumor Ablation: Standardization of Terminology and Reporting Criteria,'' Journal of Vascular and Interventional Radiology 2005; 16: 765-778.